Colonoscopy Screening for Colorectal Cancer Risk in IBD

Recruiting at10 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Colorectal cancer, Subtotal colectomy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must be in symptomatic remission, it might be important to continue any medications that help maintain this state. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of this treatment for colorectal cancer risk in IBD?

Research shows that using chromoendoscopy (a technique that uses special dyes during colonoscopy) with targeted biopsies significantly improves the detection of dysplasia (abnormal cells that can lead to cancer) compared to standard colonoscopy methods. This approach is more effective than random biopsies and is becoming the standard of care in some countries for patients with inflammatory bowel disease (IBD). ^{1 2 3 4 5}

Is colonoscopy with targeted biopsies safe for humans?

Colonoscopy with targeted biopsies is generally considered safe for humans, as it is a widely accepted method for detecting pre-cancerous changes in patients with inflammatory bowel disease. It is used in surveillance programs to prevent colorectal cancer and has been endorsed by guidelines for its effectiveness in increasing dysplasia detection. ^{1 5 6 7 8}

How is the treatment 'Colonoscopy with targeted biopsies' different from other treatments for colorectal cancer risk in IBD?

This treatment uses high-definition white light colonoscopy with targeted biopsies, which is more effective at detecting dysplasia (abnormal cells that can lead to cancer) compared to traditional methods that rely on random biopsies. It focuses on examining specific areas of concern rather than taking random samples, improving the chances of early detection of cancerous changes. ^{1 2 3 9 10}

Research Team

Eligibility Criteria

This trial is for adults over 18 with Inflammatory Bowel Disease (IBD) who are in symptomatic remission and have had IBD for at least 8 years, or any duration if they also have primary sclerosing cholangitis. They should be undergoing colorectal cancer screening with a high-definition colonoscopy but can't join if they've had major colon surgery, recent neoplasia diagnosis, poor bowel prep quality, incomplete colonoscopy, significant inflammation or a history of colorectal cancer.

Inclusion Criteria

For CD: Harvey-Bradshaw Index < 5

I am 18 years old or older.

I have had inflammatory bowel disease for 8 years or more, or I have it with primary sclerosing cholangitis.

Exclusion Criteria

I have had more than half of my colon removed.

I am scheduled for a follow-up colonoscopy due to a recent cancer diagnosis.

My colon inflammation is moderate to severe, affecting at least 25% of it, or mild but affecting at least 50%.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonoscopy with either targeted biopsies or both targeted and non-targeted biopsies

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the colonoscopy procedure

4 weeks

Treatment Details

Interventions

• Standard colonoscopy with targeted biopsies (NA)

Trial Overview The study compares two strategies during high-definition white light colonoscopies: one where only visible lesions are sampled versus the conventional method that samples both visible lesions and normal-appearing mucosa. The goal is to see which strategy is better at detecting neoplasia without being worse than the other. A total of 1952 participants will be enrolled to determine this.

Participant Groups

Group I: Experimental: Intervention Group Experimental Treatment 1 Intervention

Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.

Group II: Control Group Active Control 1 Intervention

Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Dr. Kathleen Gartke

Ottawa Hospital Research Institute

Chief Medical Officer

MD, University of Ottawa

Dr. Rebecca Auer

Ottawa Hospital Research Institute

Chief Executive Officer

MD, Memorial Sloan-Kettering Cancer Centre

Findings from Research

Chromoendoscopy with targeted biopsies significantly increases the detection of dysplasia in colitis patients, showing a 4 to 5 fold improvement compared to traditional random biopsies, and is now endorsed as the standard of care in the UK.

Recent guidelines suggest abandoning random biopsies in favor of chromoendoscopy, as it not only enhances dysplasia detection but also optimizes the overall effectiveness of colonoscopy in preventing colitis-associated colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonoscopic Cancer Surveillance in Inflammatory Bowel Disease: What's New Beyond Random Biopsy? East, JE.[2021]

Chromoendoscopy with targeted biopsies is more effective than standard white light endoscopy with random biopsies for detecting dysplasia in patients with inflammatory bowel disease (IBD), which is crucial given the high cancer risk associated with IBD.

There is a need to improve the use of chromoendoscopy in clinical practice through better training and quality metrics, as random biopsies have shown poor yield and limited clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-enhanced endoscopy is critical in the surveillance of patients with colonic IBD. Subramanian, V., Bisschops, R.[2015]

Colonoscopy has limitations in preventing colorectal cancer in patients with inflammatory bowel disease (IBD), particularly in detecting nonpolypoid colorectal neoplasms.

Chromoendoscopy with targeted biopsy significantly improves the detection of dysplasia, which is crucial for assessing colorectal cancer risk in IBD patients, and the article includes a technical guide for its effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An atlas of the nonpolypoid colorectal neoplasms in inflammatory bowel disease. Soetikno, R., Sanduleanu, S., Kaltenbach, T.[2015]

Patients with inflammatory bowel disease (IBD) have a higher risk of developing colorectal cancer (CRC), especially with extensive and long-standing disease, making effective surveillance crucial.

Advanced endoscopic imaging techniques like chromoendoscopy and magnification endoscopy may improve the detection of early neoplastic changes in IBD patients, potentially reducing the need for random biopsies and improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unveiling cancer in IBD: screening colonoscopy or chromoendoscopy. Repici, A., Laterra, MA., Cisaro, F., et al.[2019]

In a study of 110 IBD patients undergoing surveillance colonoscopy, chromoendoscopy (CE) detected nonpolypoid dysplasia in 11.8% of patients, while standard white light endoscopy (WLE) detected none, highlighting CE's superior efficacy in identifying dysplastic lesions.

The dysplasia detection rate was significantly higher with CE, showing a risk difference of 11.8% and a rate difference of 20.6 lesions per 100 patients compared to WLE, confirming CE's effectiveness in improving surveillance outcomes for colorectal cancer risk in IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chromoendoscopy versus standard colonoscopy for detection of nonpolypoid dysplasia in patients with inflammatory bowel disease. Sekra, A., Schauer, C., Mills, L., et al.[2019]

In a study of 207 IBD patients who underwent colectomy, 13% had dysplastic lesions that were undetected during prior high-definition colonoscopies, indicating a significant rate of missed diagnoses.

The undetected dysplastic lesions were more likely to exhibit nonconventional features and low-grade dysplasia, suggesting that increasing the number of random biopsies during surveillance could enhance detection rates of these lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicopathologic features of undetected dysplasia found in total colectomy or proctocolectomy specimens of patients with inflammatory bowel disease. Bahceci, D., Lauwers, GY., Choi, WT.[2022]

Patients with inflammatory bowel disease (IBD) affecting the colon have a higher risk of colon cancer, making regular endoscopic surveillance crucial for early detection.

Chromoendoscopy, which uses special dyes during colonoscopy, has been shown to significantly improve the detection of dysplasia compared to traditional white light endoscopy and random biopsies, suggesting it should be the preferred method for colorectal cancer surveillance in IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Surveillance in Long-standing Colitis. Boland, BS., Shergill, A., Kaltenbach, T.[2020]

In a study of 30 patients, chromoendoscopy (CE) significantly improved the detection of intraepithelial neoplasia (IEN) compared to white light endoscopy (WLE), with targeted biopsies revealing six cases of IEN versus none from random biopsies.

CE and confocal laser endomicroscopy (CLE) demonstrated high sensitivity (100%) and specificity (96.8% for CE) for diagnosing IEN, but CLE did not offer additional benefits over CE, indicating that targeted biopsies are more effective for screening in patients with inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer screening in patients with ulcerative and Crohn's colitis with use of colonoscopy, chromoendoscopy and confocal endomicroscopy. Hlavaty, T., Huorka, M., Koller, T., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Colonoscopic Cancer Surveillance in Inflammatory Bowel Disease: What's New Beyond Random Biopsy? [2021]

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

Image-enhanced endoscopy is critical in the surveillance of patients with colonic IBD. [2015]

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

An atlas of the nonpolypoid colorectal neoplasms in inflammatory bowel disease. [2015]

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

Unveiling cancer in IBD: screening colonoscopy or chromoendoscopy. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Chromoendoscopy versus standard colonoscopy for detection of nonpolypoid dysplasia in patients with inflammatory bowel disease. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Optimising inflammatory bowel disease surveillance and dysplasia management-Where do we stand? [2023]

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

Colorectal cancer in inflammatory bowel disease: a continuing problem. [2019]

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

Clinicopathologic features of undetected dysplasia found in total colectomy or proctocolectomy specimens of patients with inflammatory bowel disease. [2022]

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

Endoscopic Surveillance in Long-standing Colitis. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Colorectal cancer screening in patients with ulcerative and Crohn's colitis with use of colonoscopy, chromoendoscopy and confocal endomicroscopy. [2022]