Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

Overview

About this study

The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/24/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nayantara Coelho-Prabhu, M.B.B.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Francis Farraye, M.D., M.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20580118

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