Posts

You can make a difference by participating in research

Written by Linda Rice, RN, CCRC, director of clinical operations at the UK Center for Clinical and Translational Science, which is dedicated to accelerating discoveries that improve health.

Health research changes lives. It’s how we learn more about health conditions and make discoveries to improve treatments, care and diagnostics. Every medicine or device we use – from aspirin to pacemakers – was developed through a process of research. But research needs people in order to move forward. All too often, studies are forced to end early or don’t enroll enough participants, which means that many important questions go unanswered.

At UK, doctors, nurses and researchers are working diligently to advance discoveries that improve health, and we invite you to join us. You can make a difference by participating in research – you could even be part of a study whose results will help people in the future. Participating is a way to help others by “giving forward,” and it’s also an opportunity to learn more about your own health.

Whether you are healthy or have a medical condition, there are opportunities for you to participate. Health research is more than clinical trials for rare diseases. Sometimes it’s as simple as a questionnaire, a screening or helping to test a type of exercise. Many studies compensate participants.

Health research also includes extensive protection for participants. The ethical and legal codes that govern medical care also apply to research, which is further regulated with safeguards for participants. UK, like every research institution, also has a review board that evaluates all research to ensure protection of participants’ rights and welfare. Every study follows a carefully controlled plan of what researchers will do and what is asked of participants, and this plan is explained in detail before you decide to join. Participants are free to leave a study at any time.

Learn more

There are two ways to learn more and get involved in the process of discovery: You can view current research opportunities at UK, and you can also join ResearchMatch, which connects you with researchers nationwide.

Current Studies at UK: To explore opportunities to participate in ground-breaking research at UK, visit UKClinicalResearch.com and click on “Current Studies.” You can browse opportunities by topic, like Alzheimer’s disease, diabetes, cancer, healthy volunteers, women’s health, drug and alcohol use, and many others.

ResearchMatch: To join this national database of research opportunities, visit ResearchMatch.org/uky. ResearchMatch is an easy, secure, registry that unites people who are interested in research with active studies. Joining is free and fast. Simply register and wait to be contacted, or “matched,” to studies that might interest you. You can also browse studies, share ideas with researchers, and find patient organizations and health information. You always have the choice to participate or not, and you can leave ResearchMatch at any time. Individuals under the age of 19 must be enrolled by a parent or guardian.

If you’d like to learn more about health research, including frequently asked questions, please visit UKClinicalResearch.com. If you have questions about participating in research or current studies at UK, please contact us at UKClinicalResearch@uky.edu or by phone at 859-257-7856 or 859-323-8150.

Next steps:

stroke research

UK team first to offer innovative stroke care through clinical trials

The combination of a new clinical trial and a tissue bank is innovating stroke care and research at the UK. Led by a multidisciplinary team of clinicians and scientists, the two studies aim to develop new treatments using existing therapies that protect brain tissue after a stroke, and to learn more about the physiology of the event.

The MAVARIC (Magnesium and Verapamil After Recanalization in Ischemia of the Cerebrum) clinical trial leverages existing standards of care and approved drugs to improve how the brain heals following a stroke. The related BACTRAC (Blood and Clot Thrombectomy Registry and Collaboration) study is developing a tissue bank of thrombi (stroke-causing clots) and distal and peripheral blood to examine the immediate molecular changes that occur at the stroke site. Both the MAVARIC trial and the BACTRAC study are the first of their kind.

The burden of stroke is especially severe in Kentucky, where it’s the third-leading cause of death (compared to fifth nationally) and occurs at earlier ages than in the rest of the country. Globally, stroke is the leading cause of morbidity and physical incapacity.

Despite the prevalence of stroke, current standards of care include only two potential treatments. One is a drug called tPA, which, if administered quickly enough, can break up the clot that caused the stroke. This treatment, however, has a limited window of opportunity – three to four and a half hours – and can exacerbate injury if delivered too late. The second treatment option is a thrombectomy, where the clot that caused a stroke is physically removed through a catheter inserted into the blood vessel. The therapeutic window for thrombectomy is much longer, sometimes up to 24 hours.

Even with the advances of tPA and thrombectomy, which can be highly effective in removing the cause of the stroke, neither therapy treats the injury inflicted by a stroke.

“Thrombectomy has become common and widely effective, but only 60 to 70 percent of patients will be independent in three months – so there is more to be done,” said Dr. Justin Fraser, director of cerebrovascular surgery at UK and one of the principal investigators of the MAVARIC trial.

Leveraging existing drugs and modalities

In the hope of improving stroke outcomes by treating the injured area of the brain, Fraser partnered with Dr. Gregory Bix, director of the UK Center for Advanced Translational Stroke Science, to look at repurposing existing drugs that, in combination with thrombectomy, could limit brain tissue damage and promote healing in stroke survivors.

“After the clot is removed through the catheter, there’s immediate access to the site in the brain where the injury is occurring. We’re taking therapeutics that already exist and putting them into the catheter immediately after we remove the clot, so that the drug is delivered directly to the stroke-affected area of the brain,” Bix said.

Fraser and Bix began by repurposing an existing calcium channel blocker called Verapamil, which is mainly used to treat heart arrhythmias but is also FDA-approved for use to relax brain blood vessels that contract after a thrombectomy. Fraser noticed anecdotally that patients who received Verapamil during a thrombectomy had better outcomes than their imaging and symptoms would have predicted.

In a previous preclinical study and Phase I trial – the first in the world to pair thrombectomy with immediate, intra-arterial administration of a neuroprotective drug – Fraser and Bix found that intra-arteria delivery of Verapamil was safe. Furthermore, in cell culture and animal models of stroke, it was effective in preventing significant ischemia-induced injury. But they also understood that Verapamil alone wasn’t addressing the complex process of damage caused by stroke.

“There’s not going to be a single magic bullet in terms of drugs. When someone has a stroke, multiple pathways get activated and damaged. If you give a drug that addresses only one pathway, it doesn’t treat everything. So we need to try combining drugs,” Fraser said.

MAVARIC clinical trial

In the MAVARIC trial, which opened in October, Fraser and Bix are investigating whether combining magnesium with Verapamil can bestow even greater neuroprotective benefits. Magnesium has previously been studied for its potential to protect the brain after a stroke, but this trial is the first to intra-arterially deliver a neuroprotective “cocktail” to the stroke site. A total of 30 stroke patients will be enrolled; stroke size, safety, and functional and cognitive outcomes will be evaluated through randomized, blinded outcome assessment.

“By using the catheter that was inserted to remove a clot, we’re then able to deliver neuroprotective drugs directly into the brain tissue that was just reopened,” Frasier said.

The combination of Verapamil and magnesium was first validated in preclinical models before moving to a clinical trial.

“When I used these two drugs in experimental stroke models, it demonstrated very cleanly that there was a significant reduction in mean infarct volume – in other words, smaller strokes – as well as better functional outcomes. We were the first to model this completely in lab animals,” Bix said.

Because the trial uses existing FDA-approved therapeutics and modalities, the research team can conduct animal model and clinical research simultaneously, allowing them to refine the animal model as they learn more through the clinical research.

The trial also includes collaboration with Kentucky Appalachian Stroke Registry, which will enable analysis of thrombectomy and severe stroke patients who might have been candidates for the new procedure, as well as analysis of a rare but increasing stroke condition called moyamoya.

Support for the MAVARIC trial comes from the UK Multidisciplinary Value Program, which funds investigator-initiated clinical trials at UK through support from the College of Medicine, the Office of the Vice President for Research, and the Center for Clinical and Translational Science.

BACTRAC study

Leveraging thrombectomy technology even further, Fraser, Bix, and Keith Pennypacker, PhD, professor of neurology and associated director of the UK Center for Advanced Translational Stroke Science, are developing a stroke tissue bank that will greatly enhance stroke research through increased molecular understanding of the injury. The BACTRAC study is the first to collect and analyze both the stroke clots and surrounding blood. The samples are obtained as a matter of standard thrombectomy procedure and require nothing additional. The process does, however, rely on a highly collaborative process of tissue collection and informed consent that will enable inclusion of nearly every thrombectomy case at UK.

“We have a pager – we call it the Thrombectomy Pager – and when it goes off, everyone involved swarms together. One of the people who carries a pager is a researcher who will come in and process the samples on the spot. There’s centrifuge right outside the angio suite,” Frasier said.

Clot and blood samples are analyzed to examine protein, genetic and blood gas changes that occur at the stroke site. From early analysis of their first samples, the team is already noticing surprising changes in the blood and tissue where strokes occur. The observations could eventually allow for more targeted treatment of strokes.

“We’re getting the first glimpse of molecular events that are occurring due to the stroke, and some of these events are involved in signaling the immune system,” Pennypacker said. “The inflammation response is essential for the healing of the injury, but sometimes it can overreact and cause additional damage. So if we can get a handle on these molecular events, we can possibly eliminate the molecules that cause excess damage without blocking the beneficial immune molecules.”

In analyzing the first samples they collected, the team has observed calcium depletion in the blood and blood vessel distal to the clot, as well as changes in protein and RNA related to gene expression.

“We’re discovering things about stroke that no one knew six months ago – incredible changes even in single samples that could really help us understand stroke on the very acute, early side of things, which has been very difficult to study until now,” Fraser said.

Eventually, they hope, the BACTRAC study will include enough stroke cases that researchers will be able see how stroke affects people differently based on age, sex and other health conditions, such as obesity or diabetes. One limitation of current stroke research is that animal research models use predominantly young, homogeneous male mice, whereas the human population that experiences stroke is older, less healthy and much more diverse.

Such a diverse patient population is one of the main problems in finding a cure for stroke.

“In basic science animal models, we mostly use a homogeneous population, and we’ve found that they’re receptive to experimental therapies in ways that we don’t always see in humans,” Pennypacker said. “But, if we have a huge database with thousands of patients that allows us to pull out various groups and see the differences in their response to stroke, it could give insight into different treatments that work better for people based on age, sex and other health conditions.”

Initial support for the BACTRAC tissue bank comes from the UK Department of Neurology Pilot Grant Program, which funds investigator-initiated pilot studies. Further grant applications are currently underway.

Translating discoveries through team science

The multidisciplinary innovations of the MAVARIC and BACTRAC studies, which unite patient care and lab research, depend on the combined expertise of scientists, clinicians and research staff.

“There aren’t a lot of places in the U.S. that have this translational integration for stroke between basic research and clinical research,” Bix said. “What makes an academic medical center special is that we are at the cutting edge of developing new therapies. Where’s the next cure going to come from? A place like UK – an academic medical center running clinical trials it has developed itself, where people are pushing the envelope.”

To learn more these studies, visit the MAVARIC and BACTRAC clinical trial webpages.

As a designated Comprehensive Stroke Center by The Joint Commission, UK HealthCare is distinguished from other stroke centers for meeting the highest standards of care to receive and treat the most complex stroke cases.

The Multidisciplinary Value Program supports innovative, multidisciplinary clinical trials at UK. Learn more here.


Next steps:

  • Researchers are working hard to identify new treatments and strategies to improve health, but they need healthy participants and those with medical conditions to participate in clinical studies. Find out how you can participate in clinical research at UK HealthCare.
  • At the UK Comprehensive Stroke Center, we offer treatment, prevention and rehabilitation services for stroke patients. Learn more about our program.

UK researcher using $2.9M grant to treat cocaine-use disorder

Does reducing the use of cocaine, but not abstaining from the substance entirely, produce health benefits? There’s currently little research available that answers that question.

William Stoops, PhD, professor in the UK College of Medicine and director of regulatory knowledge and support for the UK Center for Clinical and Translational Science, has received a $2.9 million grant from the National Institute on Drug Abuse (NIDA) to find more answers.

Stoops hopes his research will contribute to the evolving knowledge of treatment for cocaine-use disorder (CUD), a substance-use disorder that currently has no well-established treatment methods.

“Facilities treating cocaine-use disorder are doing what they can, but there is no common practice,” Stoops said.

And while medications are available for other common substance-use disorders including opioid-use disorder and alcohol-use disorder, no medication is available to treat CUD.

Finding a more successful treatment model

Another challenge is that under the current model, CUD treatment is considered “successful” only if a patient abstains entirely from using the substance. Stoops points out that although abstinence is the ideal outcome, such a “total” fix is not the same measure of success used in treating other chronic diseases.

“Abstinence may be too high of a bar to set. We don’t do that with other chronic diseases – we focus more on reduction or management, like when treating someone for high blood pressure,” he said.

Stoops, along with interdisciplinary team members from the departments of behavioral science, psychiatry, internal medicine and psychology at UK, hope to determine if reduced cocaine use confers health benefits to individuals with CUD. He hypothesizes that a reduction will lead to improved health, and abstinence will yield even more benefits.

Health and economic benefits

The study will take place over five years and aims to enroll 200 participants (about 40 per year). Participants, who must be between 18 and 65 years old, will be asked to participate in a 12-week intervention. During the intervention, participants will need to be available three days a week for short visits. After the initial 12-week period, there will be long-term follow-up. The clinical component of the study will be conducted through the clinical services unit of the UK Center for Clinical and Translational Science.

In addition to helping people manage and treat their CUD, Stoops and the research team are also aware of the economic benefits to more people entering recovery.

“Substance use disorders in general, and CUD specifically are very expensive to the taxpayer. They lead to billions of dollars in lost productivity and healthcare costs each year,” Stoops said.

“Not having an effective, broadly used treatment, combined with the lack of a strong evidence base about whether reduced cocaine use can confer benefit, hampers our ability to help people with CUD.”

If you are interested in participating in or learning more about the study you can find more information at clinicaltrials.gov.


Next steps:

  • Researchers are working hard to identify new treatments and strategies to improve health, but they need healthy participants and those with medical conditions to participate in clinical studies. Find out how you can participate in clinical research at UK HealthCare.
  • Read how UK researchers are using an NIH grant to fight drug abuse in rural Kentucky.

How a Markey lab is helping stroke patients

When George Quintero first heard about a new clinical trial that could improve motor function in stroke patients, he knew he had to find a way to bring it to UK HealthCare.

Quintero, a research analyst for the UK Department of Neuroscience, first obtained a list of criteria to apply. The phase II trial required a physician with experience in frame-based surgery, which was easy for UK to fulfill: Dr. Craig van Horne, a neurosurgeon for the Kentucky Neuroscience Institute, has been performing this style of surgery on neurology patients for more than 20 years.

The second required element was a bit trickier. To be a treatment site for this innovative trial, the stroke team needed resources and buy-in from a stem cell lab with specific cell processing skills near the hospital.

“Originally, we thought we just needed a cell lab,” Quintero said. “We realized we didn’t have any experience in the sort of cell delivery we needed. My background is basic sciences and I have a plain cell lab, so it wouldn’t be sufficient.”

Finding the right lab

Quintero hunted for an appropriate lab across the city, beginning with UK’s Center for Clinical and Translational Science (CCTS). He combed through the work of individual investigators, and then tried to identify facilities around town that would have the means and experience to carry out the specific stem cell work needed for the trial.

After running into several dead ends, he stumbled upon the idea of bone marrow transplants, which use stem cells collected from bone marrow to repopulate the blood after aggressive treatment for blood cancers. Quintero finally had a lead: Just across the street from KNI, the UK Markey Cancer Center’s Blood and Marrow Transplantation (BMT) Program performs upward of 100 bone marrow transplants for patients each year.

Quintero reached out to Dr. Gerhard Hildebrandt, division chief of Hematology and Blood and Marrow Transplantation at UK. Although the work required was unrelated to the usual duties of the stem cell lab, Quintero says Hildebrandt was on board with the project.

“He was very excited,” Quintero said. “He thought that sort of stem cell delivery for neurological diseases would be a really advantageous thing for UK to have. So he was an early supporter of us moving forward, and he got me in touch with the group at the cell lab.”

Working together to improve patient care

Tucked away on the second floor of Albert B. Chandler Hospital, the three staff members of UK’s stem cell lab – lab manager Rita Hill and medical technologists Martha Pat Kinney and Giovi Hidalgo – quietly and efficiently go about their work of preparing stem cells for bone marrow transplant patients at the UK Markey Cancer Center.

Overseen by Dr. Roger Herzig, medical director of Markey’s Blood and Marrow Transplant Program, the lab processes stem cells for both autologous transplants – those using the patient’s own stem cells – and allogenic transplants, in which stem cells harvested from related or unrelated donors are used.

When presented the opportunity to help KNI participate in this trial, Herzig was immediately interested, having previously collaborated on other projects at UK HealthCare. Hill says the team wanted to help but had some initial reservations because of their already busy workload – to do the study, the Markey stem cell team would have to take on additional work outside of their usual service area.

“I first met Dr. Quintero and he gave us a protocol to look at, and wanted to know if we were interested,” Hill said. “We thought, ‘Yes.’ But there is a time constraint and with the BMT program rolling, we weren’t sure if we could really support it.”

For the trial to work, the stem cell team would have to work closely with Quintero and van Horne to ensure seamless patient care. The lab would receive genetically modified stem cells from the pharmaceutical company, process the cells for implantation per trial protocol, and deliver them to Quintero. Once he signed off, van Horne would initiate the procedure by drilling a small hole into the patient’s skull and injecting the stem cells into the brain. Because most of the patients in the trial would be traveling long distances just for this procedure, it was essential to have the process streamlined and efficient from start to finish.

“An idea is pretty easy to have and say, ‘Let’s do this!'” van Horne said. “But when you realize all the work that has to go into these things, it’s phenomenal.”

First, scheduling was key. Hill says Quintero and van Horne were willing to be flexible on the timing of when they could bring in patients, and they worked out a schedule that wouldn’t conflict with their normal duties for Markey.

Secondly, Hill and her team looked closely at the protocol, and noted some small elements of the process that could be improved. After several conversations, the company sponsoring the trial even adopted Hill’s suggestions and implemented them at other trial sites nationwide.

“One of the advantages of having Rita is that she has a lot of expertise in managing cell labs and the requirements of cell processing,” Quintero said. “She sort of gave some direction that the study needed, and the study welcomed that because they wanted the input from individuals to make the project better.”

Culture of collaboration

This recent trial is yet another example of what van Horne describes as “the proliferation of collaborative culture to solve human problems” across UK’s academic and healthcare campuses.

“One of the things that I think is unique about UK is there’s really a culture of collaboration,” van Horne said. “I’ve previously been in other institutions where that culture doesn’t exist… It’s not, ‘This is too much, we just can’t do this,’ but ‘Oh, that’s a great idea, let’s figure out a way to make that work.’ And everybody stepped up and pitched in and made it happen.”

“This kind of collaboration is what keeps making the research and the medicine new,” Herzig said. “And that’s what keeps me coming back to work.”

It’s not the first time the stem cell lab has stepped up to help other across the medical campus. They’ve previously assisted with stem cell research in nephrology and cardiology. Participating in these outside projects has helped the team learn more about what properties stem cells possess aside from the ability to reconstitute blood, which may prove useful in future endeavors.

“Part of the academic mission is collaboration; that allows us to tackle problems that individually we can’t do,” Herzig said. “You never know what technique you have today that you’ll be able to transfer to a different situation tomorrow. The things that we’re learning from this are probably going to be helpful in other future projects.”

Hill and her team spend most of their working time in the lab, but they do personally deliver stem cells to the bone marrow transplant patients who are preparing to undergo their infusions, giving them a brief encounter with the person who will be benefiting from their work. In addition to simply “enjoying the science” of this new project, Hill says the idea of helping even more patients provides some extra personal motivation.

“Who knows, you could have a family member or loved one later on who suffers from a stroke, and this trial could benefit them in the future,” she said. “Why wouldn’t you want to help?”


Next steps:

  • Researchers are working hard to identify new treatments and strategies to improve health, but they need healthy participants and those with medical conditions to participate in clinical studies. Find out how you can participate in clinical research at UK HealthCare.
  • At the UK Comprehensive Stroke Center, we offer treatment, prevention and rehabilitation services for stroke patients. Learn more about our program.

National network gives Markey patients greater access to personalized care

The UK Markey Cancer Center has joined the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers that recognize collaboration and access to data are the keys to cancer discovery. Membership will allow Markey’s physicians and researchers to improve patient access to personalized medicine – cancer treatments targeted to the patient’s particular cancer mutation. Markey is the latest addition to this 17-member research partnership.

“It takes teamwork to make great progress in cancer treatments,” said Dr. Mark Evers, director of the UK Markey Cancer Center.

“Markey has always subscribed to this idea, utilizing the resources from a variety of experts across UK’s clinical and academic campuses to treat our patients. This new partnership with ORIEN will allow us to collaborate with some of the best cancer centers across the country, exchanging vital information back and forth that will ultimately lead to new, improved treatments becoming available for Kentuckians.”

Personalized cancer treatment

As cancer care becomes more based on genetics versus tumor types, researchers are discovering specific, often-rare mutations that lead to the disease. To develop personalized clinical trials that can target these mutations, ORIEN members pool their resources and contribute to a shared databank.

Much of their work will focus on patients with advanced primary or metastatic disease, those with limited treatment options, and patients who are likely to develop progressive disease.

ORIEN members follow the Total Cancer Care Protocol, a well-organized, collaborative approach to studying patients throughout their lifetime. Total Cancer Care provides a standard system for tracking patient data and follows the patient throughout his or her lifetime.

This gives clinicians and researchers access to a searchable, growing database of medical information from respected peers that can help them match patients to targeted treatments. This database represents one of the world’s largest clinically annotated cancer tissue repositories, comprising data from more than 200,000 participating patients.

“ORIEN will benefit Kentucky patients with cancer by matching them to clinical trials with drugs targeted to the individual molecular profile of their tumor,” said Jill Kolesar, PharmD, director of the Precision Medicine Clinic at the UK Markey Cancer Center.

“Combined with our National Cancer Institute-sponsored clinical trials, patients at Markey will have access to a large menu of precision medicine clinical trials.”


Next steps:

Owensboro Health Markey

Owensboro Health joins Markey Cancer Center Research Network

Owensboro Health has joined the UK Markey Cancer Center Research Network (MCCRN), giving patients in Western Kentucky and Southern Indiana increased access to innovative clinical research studies.

Areas of research will include epidemiology, prevention and early detection of cancer. Markey is a National Cancer Institute-designated cancer center, which means Owensboro Health will have access to NCI-led trials in addition to MCCRN trials.

“Owensboro Health is proud to join the Markey Cancer Center Research Network, which is a distinguished and recognized name in cancer care and clinical research,” Owensboro Health President and CEO Greg Strahan said. “Owensboro Health exists to heal the sick and to improve the health of the communities we serve, and this partnership is a demonstration of our commitment to both parts of that mission.”

Owensboro Health was invited to participate in the Markey Research Network based on performance and achievements. Owensboro Health’s Mitchell Memorial Cancer Center serves the health system’s coverage area, a population of nearly 400,000 people across 14 counties in Western Kentucky and Southern Indiana. More than 1,000 patients are treated at the center annually.

“By becoming a member of the Markey Research Network, Owensboro Health is showing a commitment to helping us conquer cancer in the Commonwealth,” Markey Director Dr. Mark Evers said. “Clinical trials represent the latest, best treatment options for most patients, and being able to participate in major national and regional clinical trials right here in Owensboro means that patients are able to stay close to their own support systems at home and under the direct care of their doctors here.”

Mitchell Memorial Cancer Center also holds multiple accreditations and recognitions. These include accreditation from the American College of Surgeons Commission on Cancer and the CoC’s gold award, the highest recognition that body offers. Mitchell Memorial Cancer Center is also accredited by the National Accreditation Program for Breast Centers and the American College of Radiology and is an ACR-designated lung cancer screening center.

The importance of clinical trials

Clinical trials are key to developing new methods to prevent, detect and treat cancer, and most treatments used today are the results of previous clinical studies. These may include studies in which patients who need cancer treatment receive their therapy under the observation of specially trained cancer doctors and staff. Patients who volunteer for cancer treatment studies will either receive standard therapy or a new treatment that represents the researchers’ best new ideas for how to improve cancer care.

“Cancer care is constantly improving, due in part to the groundbreaking work being done in clinical research,” said Dr. Tim Mullett, medical director of the MCCRN. “Our state has some of the worst cancer incidence and survival rates in the entire country, and we at Markey have an obligation to address this devastating disease. By increasing access to many of our current clinical trials through the Markey Research Network, we have an opportunity to make real progress in improving cancer statistics in Kentucky.”

Markey’s clinical trials focus on the prevention, early detection and treatment of cancers with the highest incidence and mortality in Kentucky. These include lung, colorectal and cervical cancers. Owensboro Health is now one of six research sites in the MCCRN, and the first site in Western Kentucky. The MCCRN includes the following sites:

  • Hardin Memorial Hospital, Elizabethtown
  • King’s Daughters Medical Center, Ashland
  • Owensboro Health
  • St. Claire Regional Medical Center, Morehead
  • St. Mary’s Regional Cancer Center, Huntington, West Virginia
  • Tri-State Regional Cancer Center, Ashland

Watch the video below to find out how the Markey Research Network is bringing the future of cancer treatment to patients all across Kentucky.


Next steps:

Specialized research nurses who work with the UK Center for Clinical and Translational Science provide outpatient, inpatient, and off-site care for research participants, along with an array of other research support services.

UK’s clinical research nurses help make discoveries happen

Across the University of Kentucky, clinical research nurses carry out clinical procedures and care for those who participate in research studies. They not only provide the best possible patient care, but they also help make discoveries that advance healthcare altogether.

Research nurses have long been at the heart of health research, but it wasn’t until late 2016 that the American Nurses Association recognized clinical research nursing as nursing specialty practice.

For Linda Rice, a registered nurse and director of clinical operations for the clinical services core (CSC) of the UK Center for Clinical and Translational Science (CCTS), the designation of a clinical nursing specialty for research means a great deal.

“It means a lot to me that my colleagues recognize our specialty – that all the time and effort and years of training are acknowledged by our board and peers,” Rice said. “I’ve enjoyed seeing my profession grow, and knowing that the decisions we make to take care of our patients are based on evidence-based research. It does take nurses to conduct successful clinical research, and they have to specifically trained – it’s a body of knowledge and experience.”

Working across medical specialties

Rice oversees a team of nurses who assist in conducting research in the CCTS inpatient and outpatient research units for adults and children. They also provide additional clinical research services, such as study coordination.

Over the last three years, the CCTS CSC has averaged between 1,200 and 1,500 inpatient bed-nights per year, 1,600 to 1,800 outpatient days per year, and 500 to 700 offsite visits per year. During this time, the clinical research nursing team has also had to perform increasingly complex tasks, such as euglycemic clamps, oral glucose tolerance tests, muscle/bone biopsies, a wide variety of infusions (like monoclonal antibodies and immunotherapies), pediatric care and off-site care.

In total, about 56 research nurses work in research across medical specialties at UK, such as cancer, neurology, surgery, neonatology/pediatrics, cardiology, behavior science and substance use disorders, emergency care, and infectious diseases.

‘Research is the hope of the future’

Rice entered the field after encountering research nursing in her undergraduate training. Hoping to use this aspect of her education, she applied for a research coordinator job. The possibility of finding ways to improve patient care has motivated her work for nearly three decades.

“I love being on the cutting edge,” she said. “I love knowing, as a nurse, what other things are out there that are being trialed to improve care for patients. I was drawn to this profession because I wanted to help people. And what better way than to be on the front end of trying to make things better? Someone told me once that without research, there is no hope. Research is the hope of the future for better health. And to help facilitate that is such a reward.”

The primary task is the same in research nursing as in standard clinical nursing: to care for people, in this case research participants. But research nurses must possess a repertoire of knowledge and skills far beyond clinical practice. They must also know the complex tiers of institutional and federal regulations that govern health research in general, as well as the intricate protocols and diverse clinical skills required by each specific research study.

No two days are alike

Kathy Holbrook is a registered nurse and is a clinical research coordinator who also works with the CCTS. She’s been a research nurse for 13 years but said that when she started in the field, she didn’t know exactly what she was getting into.

“I learned as I went along,” she said. “But you’re still a nurse first. That means you’re ensuring the health and safety of whomever you’re taking care of. For me, it’s research volunteers.”

Holbrook finds the her work in research nursing to be invigorating and appreciates that no two days are ever alike. At any given time she might be working on several research studies in different medical specialties that require her to perform an array of tasks.

“We do a lot of data collection and we make a lot of observations to support the thesis of the protocol,” Holbrook said. “We educate our participants and volunteers on what it means to be a participant in research. And research protocols have you do procedures you might not often do in bedside or clinic nursing. The variety is endless, and that’s one of the things that keeps it fresh and interesting.”

Working closely with study volunteers and researchers is another highlight of the job, Holbrook said.

“It’s very heartwarming to know that people are willing to give of themselves for altruistic reasons,” she said. “And in working with the researchers, we get to see people being creative and thinking outside of the box to really look at something differently and ask how we can do something better.”


Next steps:

  • Researchers are working hard to identify new treatments and strategies to improve health, but they need healthy participants and those with medical conditions to participate in clinical studies. Find out how you can participate in clinical research at UK HealthCare.
  • Learn more about the groundbreaking translational research happening at UK CCTS.
In the era of electronic medical records, one of the greatest opportunities for health innovation lies not in a clinic, but in medical data.

New institute at UK translates medical data into better healthcare

In the modern era of electronic medical records and increasingly sophisticated care, one of the greatest opportunities for health innovation and discoveries lies not in a lab or a clinic, but in medical data.

The progressively routine acquisition of many types of data in healthcare has created numerous opportunities, as well as challenges, in the analysis and interpretation of this data. The emerging academic discipline of data science – which covers the entire life-cycle of data collection, curation, annotation, provenance, integration, exploration, sharing, secondary use and bioinformatics analytics – has the potential to enable great advances in healthcare and medical knowledge.

At UK, the new Institute for Biomedical Informatics (IBI) is leading the effort to translate big data into usable information and leverage the latest technologies to advance biomedical sciences.

The IBI makes it easier to share medical data

A campuswide center for data-intensive, interdisciplinary research, the IBI promotes translational team science, leads informatics and data science training programs, shares research and data infrastructure and enables technology innovation. UK is uniquely positioned in this capacity because of its large health data repository housed in the UK Center for Clinical and Translational Science (CCTS) Enterprise Data Trust, which contains regional, state, and national data on clinical and health outcomes.

GQ Zhang, PhD, leads the IBI. He also serves as chief of the Division of Biomedical Informatics (BMI) in the UK College of Medicine and director of the biomedical informatics core of the CCTS. The division of BMI in the College of Medicine serves as the academic home for a group of IBI faculty, while the overlap with the CCTS BMI core connects IBI to the clinical and translational research enterprise.

“The institute is a platform where we can more readily coordinate data and informatics efforts across the entire campus, engaging in research, educational and collaborative initiatives,” Zhang said.

Collaboration fosters success

The IBI has already made great strides in its mission since it was approved by the UK Board of Trustees in June 2016. In only six months, the institute has won external funding, launched collaborative and educational initiatives, and expanded its research staff. It is also now inviting faculty to join as IBI members.

In August 2016, the IBI was awarded a $2.4 million Major Research Instrumentation Award from the National Science Foundation to create a big data computing infrastructure, called the Kentucky Research Informatics Cloud (KyRIC). KyRIC will enhance advanced computational infrastructure for accelerating scientific discovery through computational- and data-intensive research that uses the enormous amounts of data available at UK.

Collaborative team science is central to the work of the IBI. Launching and using KyRIC involves concerted effort with the UK Center for Computational Science and the research computing unit of UK Information Technology Service. The IBI also works closely with the CCTS, integrating the biomedical informatics core of the CCTS with academic and research units across the UK campus. Additionally, the IBI played an instrumental role in the CCTS’ successful application for a second $20 million Clinical and Translational Science Award from the National Institutes of Health, awarded in August 2016.

Extending work beyond campus

The IBI has also started working with the UK Office of Technology Commercialization (OTC) for invention and commercialization opportunities. Potential collaborative projects include patent applications for IBI’s inventions in data management and visualization platforms.

“We plan to work very actively together on a number of fronts, because we are one of the most software- and informatics-intensive units on campus. We create tools and there’s a lot of synergy in tying such efforts to tech transfer,” Zhang said. “I think both parties are very excited because software and technology remain among the most active business sectors for innovation.”

IBI’s collaborations extend beyond campus, as well. The institute serves as the data coordination center of the Center for SUDEP (sudden and unexpected death of a person diagnosed with epilepsy) Research at Case Western Reserve University. Zhang also serves as one of the principal investigators on a collaboration with Harvard University to develop a big data resource called the National Sleep Research Resource (NSRR), which provides access to a rich collection of sleep research data collected on children and adults across the U.S. Both collaborations are funded by the National Institutes of Health.

The IBI is growing rapidly

To support its rapidly growing portfolio of research, educational offerings and collaborations, the IBI has hired two new faculty members and is currently recruiting assistant, associate or full professors in the division of biomedical informatics in the UK College of Medicine. IBI and university leadership are also considering the possibility of establishing a campus-wide graduate informatics program with multiple curricula pathways from data to discovery.

“Leveraging UK’s wealth of data is central to our mission to improve care, make health discoveries, and train the upcoming generation of health professionals and researchers,” said UK Provost Tim Tracy. “The creation of the IBI reflects the university’s commitment to addressing the challenges and opportunities associated with big data. In a short time, the IBI has established robust infrastructure and expertise in informatics that will no doubt lead to exciting opportunities for discovery and learning.”


Next steps:

Some patients who receive brain tumor radiation develop radiation necrosis, causing debilitating effects. But a new clinical trial could change that.

UK and Norton partner in first-ever clinical trial for radiation necrosis

Radiation saves countless lives, but in rare cases, it causes a debilitating complication. Around 3 to 5 percent of patients who receive radiation for brain tumors, or arteriovenous malformations (AVM), develop radiation necrosis.

Radiation necrosis causes headaches, nausea and vomiting, cognitive problems, and neural dysfunction. Although a variety of medications has been used to manage symptoms, there is no approved cure. But a joint clinical trial at Norton Brownsboro Hospital in Louisville and UK HealthCare could change that.

The first trial of its kind that treats the brain directly

Led by Dr. Shervin Dashti and Dr. Tom Yao from the Norton Neuroscience Institute and Dr. Justin Fraser at UK HealthCare, the trial is the first in the world to deliver a dose of a cancer drug directly to the brain. This allows a larger amount of the drug to reach the brain, making treatment more effective.

Dashti has seen the effects of radiation necrosis on patients who have already experienced the trauma of brain cancer or AVM. In addition to the symptoms caused by the condition itself, patients suffer from side effects of steroids used to manage it: insomnia, mood changes and weight gain.

“There was nothing that worked for treating it, and people were devastated,” he said. “What we’re doing now is something completely different, and I think it has a chance to really change the way we treat this.”

More than three years ago, Dashti developed this treatment when two young patients were in desperate need. Only 12 and 13, both girls had developed radiation necrosis and were experiencing severe side effects from steroids. They had disabling headaches, gained 50 to 60 pounds each, missed significant amounts of school or withdrew entirely. One patient experienced focal seizures in her arm and leg; the other patient was hospitalized for fluid overload.

With no other treatment available, Dashti and Yao spoke to the first patient and her family about trying a low dose of Avastin directly to the brain. They agreed, and within 12 hours of the procedure, her headaches were gone. Brain scans over several months showed continuous improvement, her arm and leg had strengthened so she could walk without help, and she returned to school.

Jade Cain, now 16, was the second patient. She was 11 when the AVM was diagnosed and 13 when she met Dashti. According to her mother, Desiree Fischer, 75 percent of her brain was swollen by that time, and she was so depressed she didn’t want to leave the house.

“We’d been doing three or four months of steroids, and she ended up on all other kinds of other medications, too, because she developed thrush. So that’s what led us to this procedure. She spent a week in the children’s hospital because she was in fluid overload. She couldn’t do any more steroids because that was going to kill her.”

Fortunately, the treatment worked just as well for Cain. Her headaches went away, she was off steroids within four weeks, and she returned to school.

She had a final angiogram of her brain in March 2016, and everything was normal.

“It the most amazing, complete response after one treatment, and the imaging response was unbelievable. It was a miraculous recovery for both of them,” Dashti said.

Partnering with UK HealthCare

The success of these two patients motivated Dashti to start a clinical trial. He asked Fraser, director of cerebrovascular surgery and surgical director of the comprehensive stroke center at UK’s Kentucky Neuroscience Institute, to join them.

“We’re in this position of facing an uncommon complication of a treatment that is becoming more commonly used, and we don’t have a great way to fix it,” Fraser said. “What’s special about our procedure is that patients get the drug once, directly to the brain, as opposed to a complete course of the drug that can cause serious side effects.”

The trial is supported by both institutions and has received expert project management support from the UK Center for Clinical and Translational Science.

Showing gratitude and support

Cain’s family has raised more than $20,000 for the Children’s Hospital Foundation. At the decision of Cain and her mother, these funds are directed specifically to support research on radiation necrosis.

“From the steroid use, my child who weighed 105 pounds went up to 160 pounds in one month. Had this treatment already been approved, we could have omitted all that. She battled to get the weight off and to overcome poor body self-image,” Fischer said. “I wish it had been approved way before. And I hate that my child is the one who had to go through it, but I tell her, ‘You have no idea what you’ve done – you’ve paved the way so other people hopefully won’t have go through what you went through.’”

If you are interested in learning about participating in this study, please contact Elodie Elayi at elodie.elayi@uky.edu, or review the study information at ClinicalTrials.gov.


Next steps:

  • UK’s Center for Drug and Alcohol Research has recently made progress on a treatment for those with opioid use disorder. Learn more.
  • Clinical research helps develop the treatments and medications of the future. Learn how you can help.

Promising results in UK clinical trial get opioid therapy closer to market

A clinical trial at the UK Center on Drug and Alcohol Research (CDAR) revealed a promising therapy for moderate-to-severe opioid use disorders.

The randomized, double-blind clinical trial compared weekly and monthly dosage of CAM2038, a buprenorphine therapy developed by Braeburn Pharmaceuticals and Camurus, with the current standard of care: a daily dose of buprenorphine/naloxone.

Reaching a milestone for FDA approval

Led by Dr. Michelle Lofwall in UK’s CDAR, the trial established the drug’s non-inferiority to the current treatment, a critical milestone in the application for FDA approval. While results indicated CAM2038 met non-inferiority, a key secondary outcome also demonstrated that CAM2038 was superior to current standard treatment, based on a pre-defined distribution of illicit opioid use.

Opioid overdoses cause more than 30,000 deaths every year, and 2.6 million Americans suffer from an opioid use disorder. More than 12 million people misused a prescription opioid pain reliever and 800,000 used heroin in 2015. The National Institutes on Drug Abuse has called for safe, proven solutions to initiate treatment and stabilize patients through an extended opioid recovery program. The Surgeon General’s Report called for more access to evidence-based effective treatments, like buprenorphine, for opioid use disorders.

The study’s positive results provided the necessary evidence for entering the FDA-approval submission process. Evidence suggests people with a moderate-to-severe opioid use disorder might benefit from receiving an injectable therapy administered on a weekly or monthly basis. The weekly injection is appropriate for induction and initial stabilization, and the monthly injection is better for stabilized patients. Together, both weekly and monthly medications allow for individualized dosing, which is critical for optimal patient outcomes and recovery from a deadly disease.

Eliminating stigmas

Lofwall, a psychiatrist and associate professor in the UK College of Medicine, served as principal investigator on the study, along with Sharon Walsh, director of the CDAR. Lofwall, who sees patients’ personal struggles with opioid use disorder in clinical practice, stresses the need for progressive and practical therapies to treat opioid addiction. An injectable therapy administered in a clinician’s office eliminates the risk of diverting traditional forms of buprenorphine and decreases the risk of relapse and overdose. The discreet nature of the therapy also eliminates any stigma and shame felt by patients taking oral opioid maintenance medications in daily life.

“If approved, the CAM2038 weekly and monthly injectable buprenorphine medications can improve how we treat opioid addiction and decrease the stigma associated with the medication that is in large part due to concerns about non-adherence and diversion,” Lofwall said. “Together with the six-month buprenorphine implant, these new long-acting medication delivery systems would allow us to administer a proven medication to the patients directly, leading to improved medication efficacy as demonstrated in this trial as well as avoiding the potential for missed or stolen doses, diversion or accidental pediatric exposure, which are significant public health concerns.”

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges.


Next steps: