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Search / Trial NCT06560021

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

Ibd Uc Inflammatory Bowel Diseases Colonoscopy Random Biopsies Crohn's Disease Ulcerative Colitis

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.

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

0 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