Utility of Random Biopsies in Patients With Inflammatory Bowel Disease

NCT06560021 | Enrolling By Invitation DMC

• 2 other identifiers: 15225U01DK138901
• Study Type: interventional
• Target: 1,642
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

IBD; UC; inflammatory bowel diseases; colonoscopy; random biopsies; Crohn's disease; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• number of dysplastic or SSA lesions detected per colonoscopy

  The rationale for this as the primary outcome is that it is important to detect and remove all precancerous lesions. For this outcome, the investigators will include low grade dysplasia (LGD), high grade dysplasia (HGD), SSA or CRC but not indefinite for dysplasia (IFD). Dysplasia will include both conventional and nonconventional forms of dysplasia. Although SSAs do not typically have histologic changes of dysplasia, they are considered precancerous lesions and are more difficult to detect than sporadic adenomatous polyps. The number of dysplastic or SSA lesions will be defined as the number of pathology jars containing a specimen with low-grade or high-grade dysplasia (including CRC) or serrated changes consistent with a sessile serrated adenoma-like change. Even if there are more than one biopsy sample in a jar with dysplasia or SSA, it will be counted as one location with dysplasia or SSA.

  At index colonoscopy

Study Arms (2)

Limited biopsy strategy

ACTIVE COMPARATOR

Targeted biopsies plus 2 random biopsies in 2 segments to assess for inflammation

Other: Biopsy strategy

Random biopsy strategy

ACTIVE COMPARATOR

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

Other: Biopsy strategy

Interventions

Biopsy strategy OTHER

Number of random biopsies, in addition to targeted biopsies, taken during colonoscopies where at least one indication for the colonoscopy is surveillance for dysplasia

Limited biopsy strategy; Random biopsy strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (defined as 2 segments of the remaining colon; segments include right colon, transverse colon, left colon and rectum).
• Disease duration must meet one of the following criteria:
• onset of symptoms of IBD at least 8 years prior
• diagnosis of IBD at least 8 years prior
• diagnosis of IBD for any duration if other risk factors for colon cancer are present including: concomitant diagnosis of primary sclerosing cholangitis, personal history of dysplasia, sessile serrated adenoma or right sided hyperplastic polyps greater than 10mm in diameter, or a family history of colon cancer in a first degree relative or two second degree relatives.
• Scheduled to undergo colonoscopy as part of routine care
• At least one indication for the index colonoscopy must be to perform dysplasia surveillance.

You may not qualify if:

• 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
• Less than 2 segments of the remaining colon have ever been involved with IBD
• Colonoscopy\* in the last 11 months unless the colonoscopy:
• was determined by the endoscopist to be insufficient for dysplasia surveillance and,
• did not include a diagnosis of dysplasia or sessile serrated adenoma. \*Does not include sigmoidoscopy
• Inability to provide informed consent

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (19)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Scripps Health

San Diego, California, 92121, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

AdventHealth

Orlando, Florida, 32804, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• James D Lewis, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The endoscopist will not be informed of the biopsy strategy until he/she is ready to insert the scope. Participants will not be informed of the randomization until the colonoscopy is completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter parallel group clinical trial

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (19)