Biopsy Strategy for Inflammatory Bowel Disease

(URBI Trial)

Recruiting at 17 trial locations

Overseen By Brittaney Bonhomme, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Colorectal cancer, Dysplasia, Adenoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: At index colonoscopy

1642 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two biopsy methods to determine which better detects early signs of cancer or pre-cancer in individuals with inflammatory bowel disease (IBD). The study compares a limited biopsy approach with a more extensive, random biopsy method during colonoscopies. It targets individuals with ulcerative colitis or colonic Crohn's disease affecting a significant portion of their colon for over 8 years, who are scheduled for routine colonoscopies. Participants must not have undergone a colonoscopy in the last 11 months. The goal is to improve how doctors monitor IBD patients for potential complications. As an unphased trial, this study allows participants to contribute to important research that could enhance future monitoring and care for IBD patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these biopsy strategies are safe for patients with inflammatory bowel disease?

Research has shown that the safety of the biopsy methods for inflammatory bowel disease (IBD) is generally well understood. Studies have not identified specific harmful effects from the random biopsy method, which primarily helps detect colorectal cancer in people with IBD. Although its effectiveness is debated, studies have not raised particular safety concerns.

For the limited biopsy method, studies lack detailed safety information. However, research often emphasizes its ability to detect changes in the colon. Since these biopsy methods are part of routine colonoscopy procedures, which are widely used, they are generally considered safe.

Both biopsy methods are common in medical practice for monitoring IBD. Although studies do not provide specific safety details, these methods are well-established in current medical procedures, suggesting they are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new biopsy strategies for managing Inflammatory Bowel Disease (IBD). Unlike traditional approaches that often rely on random biopsies without clear guidance, this trial compares two innovative methods: a random biopsy strategy and a limited biopsy strategy. The random biopsy strategy aims to be thorough by taking biopsies every 10 cm throughout the colon, specifically targeting areas previously affected by IBD. Meanwhile, the limited biopsy strategy focuses on targeted biopsies and a few random ones to efficiently assess inflammation. These methods could potentially improve detection and monitoring of IBD, leading to better tailored treatments for patients.

What evidence suggests that this trial's biopsy strategies could be effective for detecting dysplasia in inflammatory bowel disease?

This trial will compare two biopsy strategies for inflammatory bowel disease (IBD). Research has shown that random biopsies, one of the strategies in this trial, can detect about 10% more cases of abnormal cell growth in people with IBD. Nearly 20% of these cases are discovered with random biopsies, particularly in patients with higher risk factors. The other strategy, the limited biopsy strategy, aims to be equally effective but with fewer biopsies. This method focuses on checking for inflammation and might simplify the process without missing important findings. Both strategies offer advantages, and ongoing studies aim to determine which works best in different situations. ^{1 2 3 5 6}

Who Is on the Research Team?

James D Lewis, MD, MSCE

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am scheduled for a routine colonoscopy.

My colonoscopy is for checking cell changes that could turn into cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high-definition white light colonoscopy (HDWLC) with either a limited or random biopsy strategy

At index colonoscopy

1 visit (in-person)

Follow-up

Participants are monitored for detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy

Up to 15 years

Follow-up via chart review

What Are the Treatments Tested in This Trial?

Interventions

• Biopsy Strategy

Trial Overview 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.

How Is the Trial Designed?

Group I: Random biopsy strategy Active Control 1 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 strategy Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study of 68 biologic-naïve patients with inflammatory bowel disease (IBD), over 53% experienced adverse drug reactions (ADRs) during treatment, highlighting the need for careful monitoring of safety in these patients.

The most common ADRs were mild to moderate, primarily related to general disorders and administration reactions, with infections being less frequent and rarely causing treatment discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series. Larussa, T., Basile, A., Palleria, C., et al.[2022]

In a systematic review of 20 studies involving patients with inflammatory bowel diseases (IBD), vedolizumab showed a lower risk of serious infections compared to TNFα antagonists specifically in patients with ulcerative colitis, but not in those with Crohn's disease.

Ustekinumab was found to have a significantly lower risk of serious infections compared to TNFα antagonists and vedolizumab in patients with Crohn's disease, suggesting it may be a safer option for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Risk of Serious Infections With Biologic Agents and Oral Small Molecules in Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis. Solitano, V., Facciorusso, A., Jess, T., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06560021

Utility of Random Biopsies in Patients With Inflammatory ... The primary objective of the study is to determine if HDWLC using a limited biopsy strategy is non-inferior to HDWLC using a random biopsy strategy to detect ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7008150/

Outcomes and Strategies to Support a Treat-to-target ... A treat-to-target strategy may impact on disease progression and improve outcomes in inflammatory bowel disease. Prospective studies including long-term data ...

3. cghjournal.org cghjournal.org/article/S1542-3565(24)00556-1/fulltext

Additional Yield of Random Biopsy in Patients With ... There are limited clinical data regarding the additional yields of random biopsies (RBs) during colorectal cancer surveillance in patients with inflammatory ...

4. withpower.com withpower.com/trial/phase-ulcerative-colitis-11-2024-95d45

Biopsy Strategy for Inflammatory Bowel Disease (URBI Trial) In a study of 68 biologic-naïve patients with inflammatory bowel disease (IBD), over 53% experienced adverse drug reactions (ADRs) during treatment, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1542356525006160

Advancing Inflammatory Bowel Disease-Driven Colorectal ... Yet, with advancing technology, biopsy-free strategies and AI-driven real-time diagnostics are set to transform IBD surveillance. Advanced ...

6. gut.bmj.com gut.bmj.com/content/early/2025/04/29/gutjnl-2025-335023

British Society of Gastroenterology guidelines on colorectal ... Patients with inflammatory bowel disease (IBD) remain at increased risk for colorectal cancer and death from colorectal cancer compared with the general ...