Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
Launched by UNIVERSITY OF PENNSYLVANIA · Aug 15, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This clinical trial is looking at two different methods of performing colonoscopy in patients with inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis. Specifically, the study will compare a limited biopsy strategy, which involves taking a few random samples from specific areas of the colon, to a random biopsy strategy, where more samples are taken from various parts of the colon. The goal is to see which method is better at detecting early signs of abnormal growths, known as dysplasia or sessile serrated adenomas, during follow-up colonoscopies.
To participate in this trial, you should have been diagnosed with left-sided ulcerative colitis or extensive ulcerative colitis, or have colonic Crohn's disease that affects at least one-third of your colon and has been present for at least eight years. You also need to be scheduled for a colonoscopy as part of your routine care and haven’t had one in the last 11 months. If you join the study, you may be followed for up to 15 years to track your health outcomes. This trial is currently recruiting participants of all genders between the ages of 65 and 74.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of left-sided (greater than 15 cm of disease but not beyond the splenic flexure) or extensive (extending beyond the splenic flexure) ulcerative colitis or IBD-U or colonic Crohn's disease involving at least 1/3 of the colon for at least 8 years
- • Patients who are scheduled to undergo colonoscopy as part of routine care.
- • At least one indication for the index colonoscopy must be to perform dysplasia surveillance.
- • Has not had a colonoscopy in the last 11 months
- Exclusion Criteria:
- • Any condition that the endoscopist feels is a contraindication to random biopsies
- • History of visible (high or low grade) dysplasia not completely removed
- • History of sessile serrated adenoma not completely removed
- • History of colorectal cancer
- • Any condition for which the endoscopist feels that pancolonic contrast or virtual chromoendoscopy is mandatory
- • Inability to provide informed consent
About University Of Pennsylvania
The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Rochester, Minnesota, United States
Jacksonville, Florida, United States
Seattle, Washington, United States
Chapel Hill, North Carolina, United States
Baltimore, Maryland, United States
Patients applied
Trial Officials
James D Lewis, MD, MSCE
Principal Investigator
University of Pennsylvania
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported