Biopsy Strategy for Inflammatory Bowel Disease

(URBI Trial)

Recruiting at 7 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?

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.

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.

Is the biopsy strategy for inflammatory bowel disease safe for humans?

Ileocolonoscopy, which includes biopsies, is generally used to diagnose and monitor inflammatory bowel disease, but there is limited data on its safety, especially in patients with severe inflammation. ^{1 2 3 4 5}

How does the biopsy strategy for inflammatory bowel disease differ from other treatments?

This treatment is unique because it focuses on using biopsies as a diagnostic and therapeutic tool, which helps in the initial evaluation and long-term observation of inflammatory bowel disease, rather than relying solely on medication or surgery. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Biopsy Strategy for Inflammatory Bowel Disease?

Research suggests that rectal biopsies, when done carefully, can be helpful in diagnosing and monitoring inflammatory bowel disease. Additionally, optical biopsy techniques like confocal laser endomicroscopy can assess inflammation and detect early changes in the bowel lining. ^{6 7 11 12 13}

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+

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. United States pubmed.ncbi.nlm.nih.gov

Usefulness of rectal biopsy in inflammatory bowel disease. [2004]

2. England pubmed.ncbi.nlm.nih.gov

How could pathologists improve the initial diagnosis of colitis? Evidence from an international workshop. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Beyond white light endoscopy: the role of optical biopsy in inflammatory bowel disease. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Improved diagnostic accuracy of inflammatory bowel disease: a clinicopathological collaborative approach. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating the optimum number of biopsies to assess histological inflammation in ulcerative colitis: a retrospective cohort study. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety, feasibility, and tolerability of ileocolonoscopy in inflammatory bowel disease. [2008]

7. Romania pubmed.ncbi.nlm.nih.gov

Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and Monitoring of Inflammatory Bowel Disease Advanced Therapies. [2023]

9. United States 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. [2023]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Novel Targets For Therapeutic Intervention in Inflammatory Bowel Disease. What is the Best Way to Assess the Safety Profile of a Drug? [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Jumbo forceps are superior to standard large-capacity forceps in obtaining diagnostically adequate inflammatory bowel disease surveillance biopsy specimens. [2008]

12. England pubmed.ncbi.nlm.nih.gov

Inflammatory bowel disease biopsies: updated British Society of Gastroenterology reporting guidelines. [2021]

13. Australia pubmed.ncbi.nlm.nih.gov

Observer variation of diagnoses based on simple biopsy criteria differentiating among Crohn's disease, ulcerative colitis, and other forms of colitis. [2019]