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Random versus Limited Biopsies for the Detection of Precancerous Changes in the Colon among Patients with Inflammatory Bowel Disease, The URBI Study
Trial Status: active
This clinical trial compares random versus limited biopsies in detecting precancerous changes in the colon among patients with inflammatory bowel disease (IBD). People with Crohn’s disease or ulcerative colitis, conditions referred to as IBD, have an increased risk of developing colon cancer. Doctors try to reduce that risk by finding and removing precancerous lesions. This is done with a colonoscopy performed every few years. At the time of the colonoscopy, the doctor looks carefully for lesions that appear to be precancerous and will biopsy or remove the lesions. In addition, doctors take biopsies of normal-appearing colon to look for inflammation and invisible precancerous changes. Researchers believe that nearly all precancerous lesions can be seen and that careful examination of the lining of the colon is the most effective way to find and remove the precancerous lesions before they turn into cancer. Prior studies suggest that taking additional biopsies of normal appearing colon may be both beneficial and harmful. It could be helpful by finding invisible precancerous changes. It could be harmful if taking additional biopsies distracts the doctor from finding and removing visible precancerous changes. Not taking as many biopsies may lower the risk of bleeding and may shorten the time under anesthesia. This trial may help researchers determine which biopsy approach is more effective at detecting precancerous changes.
Inclusion Criteria
Adults 18 years of age and older
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 inflammatory bowel disease undefined (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 (CRC)
Any condition for which the endoscopist feels that pancolonic contrast or virtual chromoendoscopy is mandatory
Inability to provide informed consent
Additional locations may be listed on ClinicalTrials.gov for NCT06560021.
I. Determine if high-definition white light colonoscopy (HDWLC) using a limited biopsy strategy is non-inferior to HDWLC using a random biopsy strategy to detect dysplasia or sessile serrated adenoma (SSA) in patients with IBD.
SECONDARY OBJECTIVES:
I. Determine if HDWLC using a limited biopsy strategy is superior to HDWLC with a random biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD.
II. Determine whether the number of targeted biopsies differs based on the number of random biopsies obtained.
III. Define the molecular characteristics of the progression of colitis-associated dysplasia.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (LIMITED STRATEGY): Patients undergo biopsy during standard of care (SOC) HDWLC on study and have 2 untargeted samples and 2 targeted samples taken.
ARM II (RANDOM STRATEGY): Patients undergo biopsy during SOC HDWLC on study and have up to 32 samples taken, untargeted and targeted.
After completion of study intervention, patients are followed for 15 years.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
