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Biopsy Strategy for Inflammatory Bowel Disease (URBI Trial)

N/A

Recruiting

Led By James D Lewis, MD, MSCE

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at index colonoscopy

Awards & highlights

No Placebo-Only Group

Summary

This trial will involve 821 patients in each group who will undergo either targeted biopsies in 4 segments with limited biopsies or targeted biopsies plus 4 biopsies every

Who is the study for?

This trial is for patients with certain types of Inflammatory Bowel Disease (IBD) such as Ulcerative Colitis or Crohn's affecting at least one-third of the colon, and who have had the condition for over 8 years. Participants must be due for a routine surveillance colonoscopy to check for cell changes that could lead to cancer.

What is being tested?

The study compares two strategies during a colonoscopy: one takes fewer random tissue samples (biopsies) from four segments, while the other takes more biopsies throughout the entire affected area. The goal is to see which method is better at detecting abnormal cells over time.

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort, bleeding, or infection at biopsy sites; bowel perforation; and reactions related to sedation used during colonoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a specific type of bowel disease for at least 8 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at index colonoscopy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at index colonoscopy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at index colonoscopy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

number of dysplastic or SSA lesions detected per colonoscopy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Random biopsy strategyActive Control1 Intervention

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

Group II: Limited biopsy strategyActive Control1 Intervention

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

0 / 1Eligibility criteria met