Comprehensive Esophageal Health Center opens with more convenient, streamlined care
Simultaneous National Institutes of Health (NIH) U01 grants support The Ohio State University Wexner Medical Center’s Division of Gastroenterology, Hepatology and Nutrition as it participates in two high-impact research consortia. One study group focuses on chronic pancreatitis, diabetes and pancreatic cancer, while the other focuses on the connections between acute pancreatitis and diabetes.
“These are once-in-a-lifetime opportunities that were formed because the NIH thinks these are high-priority areas of focus and has allocated the funds to complete work that would otherwise not be feasible,” says Phil Hart, MD, the division’s director of the Section of Pancreatic Disorders, director of Clinical Research and a clinical professor of Internal Medicine. Ohio State was selected to join other top institutions throughout the country to work collaboratively. The NIH provides U01 grants to address research questions that cannot be answered by a single site, Dr. Hart says.
Involvement from the Ohio State Clinical Center to these consortia consists of servant leadership, participant engagement and enrollment, scientific development and scholarly output.
Patients now take part in these national studies through observational research. Soon clinical trials will provide opportunities for our patients to access novel treatments for pancreatitis, Dr. Hart says.
Complementary, collaborative work
While both consortia are thematically related, they’re administered independently. Success depends on everyone working together. The number of physician-investigators and research, administrative and other support staff is a remarkable attribute of these groups.
Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer
The Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC) formed in 2015. The group is working to answer several questions related to understanding the connection between chronic pancreatitis, diabetes and pancreatic cancer. Pancreatic cancer is the third most common cause of cancer-related death because most people are diagnosed at a late stage.
“We believe that diabetes is the first ‘symptom’ of pancreatic cancer for many individuals, but identifying who will develop cancer within a large group of adults with diabetes is like finding a needle in the haystack,” Dr. Hart says. “We are actively involved with investigating markers that may help us to be successful in early detection of pancreatic cancer.”
Other questions the CPDPC is trying to address include:
- How and why does pancreatitis advance into acute and chronic subtypes in certain patients?
- Why is diabetes a common complication of chronic pancreatitis, and how can we prevent it?
- What makes pancreatitis a risk factor for pancreatic cancer?
“Along the way, we can learn and characterize a lot about pancreatitis, which has never really been studied in a large, organized way,” Dr. Hart says.
Ohio State is a top enrolling center for three of the CPDPC’s adult studies. A fourth focuses on pediatrics. Dr. Hart leads the Clinical Center at Ohio State. The center’s team of investigators leads two of the three studies and adult working groups.
Patients are followed longitudinally, and information about their care, quality of life and lifestyle is collected. These data go beyond the standard of care and are designed to identify potential interventions, such as biomarkers, that could lead to better diagnostic methods and treatments.
Ohio State has proposed two different studies related to the early diagnosis of chronic pancreatitis and pancreatic cancer, Dr. Hart says.
First, using a network of nine additional academic centers, the team is investigating the ability to diagnose early chronic pancreatitis by detection of unique proteins in body fluids (urine or blood).
Second, the group is examining the ability to diagnose diabetes secondary to pancreatic cancer from the more common type 2 diabetes by comparing changes in pancreatic hormones measured in the blood.
Type 1 Diabetes in Acute Pancreatitis Consortium
The Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC) is the second consortium, formed in 2020 to answer the overarching questions, “How common is the development of diabetes after acute pancreatitis, and what causes it?”
The T1DAPC has a primary study that’s currently enrolling, with a goal of 1,200 participants.
The Ohio State Clinical Center investigators co-lead several of the working groups and committees for this project: Protocol Committee, Pancreatitis Working Group, Biospecimens Committee and Recruitment/Retention Committee. The team is co-led by Dr. Hart and Georgios Papachristou, MD, PhD, professor of Internal Medicine, at Ohio State.
The work will allow researchers to answer primary questions about diabetes, and opens the door to careful study of acute pancreatitis. Each center will systematically collect data and information such as biologic samples of blood, saliva and stool; computed tomography scan images; and answers to patient questions about how they feel, their lifestyle and their medical history.
“This gives us a platform to understand, learn and study new treatments and interventions in diet and medicine for this patient population,” Dr. Hart says.
Up next: Clinical trials
Both consortia are ultimately aiming toward clinical trials to directly study how to improve the care of patients. The studies are gathering fundamental information in a manner that makes sense scientifically.
U01 projects are funded in five-year increments. Dr. Hart says Ohio State hopes for additional rounds of funding in the future. He’s thankful for opportunities to work with experts from other institutions and for patients willing to take part in the research.
“These are necessary building blocks to designing rigorous clinical trials,” Dr. Hart says. “We look forward to learning more and reporting for the first time ever on how we can improve quality of life for our patients.”
