Colonoscopy Screening for Colorectal Cancer Risk in IBD

Recruiting at 10 trial locations

Overseen By Sanjay Murthy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Colorectal cancer, Subtotal colectomy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1952 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to screen for colorectal cancer in people with inflammatory bowel disease (IBD). It compares two approaches during a routine colonoscopy: one that takes biopsies only from visible lesions and another that also takes random biopsies from normal-looking areas. Individuals who have had IBD for over eight years and are in symptomatic remission (no active symptoms) during a colonoscopy may qualify for this trial. The goal is to identify the most effective method for detecting early signs of cancer. As an unphased study, this trial provides an opportunity to contribute to important research that could enhance cancer screening for others with IBD.

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 prior data suggests that this colonoscopy method is safe for colorectal cancer screening in IBD patients?

Research shows that colonoscopy, particularly with targeted biopsies, is generally safe for people with inflammatory bowel disease (IBD). Studies have found that most patients tolerate this procedure well. Serious side effects rarely occur, though some individuals might experience minor discomfort or bleeding, which typically resolves quickly.

Overall, evidence supports the safety of standard colonoscopy with targeted biopsies for detecting colorectal cancer in people with IBD. This method identifies pre-cancerous growths while avoiding unnecessary procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more targeted approach to colonoscopy for people with inflammatory bowel disease (IBD) who are at risk for colorectal cancer. Unlike the standard method, which involves taking random biopsies during the procedure, this trial emphasizes targeted biopsies of pre-cancerous lesions seen by the doctor. This method has the potential to be more precise, possibly leading to earlier detection and removal of harmful polyps, improving patient outcomes. By focusing on targeted biopsies, the trial aims to enhance the effectiveness of routine IBD surveillance and could pave the way for more personalized screening strategies.

What evidence suggests that this colonoscopy method is effective for colorectal cancer risk in IBD?

Research shows that high-definition white light colonoscopy effectively finds colorectal polyps in people with inflammatory bowel disease (IBD). Studies have found that this method detects pre-cancerous growths better than older techniques. This is important because people with IBD face a higher risk of developing colorectal cancer. In this trial, participants in the intervention group will undergo standard colonoscopy with targeted biopsies, where doctors take samples from visible growths. This approach has proven practical for finding abnormal tissue growth. The evidence supports its use due to its effectiveness in identifying potential cancerous changes. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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

I am not experiencing symptoms at the time of my colonoscopy.

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%.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Standard colonoscopy with targeted biopsies

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.

How Is the Trial Designed?

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.

Standard colonoscopy with targeted biopsies is already approved in European Union, United States for the following indications:

Approved in European Union as Colonoscopy with targeted biopsies for:

• Colorectal neoplasia screening in patients with inflammatory bowel disease

Approved in United States as Colonoscopy with targeted biopsies for:

• Colorectal neoplasia screening in patients with inflammatory bowel disease

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

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]

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]

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]

Patients with longstanding extensive colitis are at a higher risk for colorectal cancer, necessitating regular colonoscopy screenings to detect pre-cancerous changes, but current programs struggle with low enrollment and missed lesions.

There is a critical need for more research into non-invasive markers to assess colorectal cancer risk in patients with inflammatory bowel disease, as managing dysplastic lesions remains complex and uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising inflammatory bowel disease surveillance and dysplasia management-Where do we stand? Al Bakir, I., Kabir, M., Yalchin, M., et al.[2023]

Patients with inflammatory bowel disease (IBD) are diagnosed with colorectal cancer at a younger average age of 48, often after a long duration of IBD (19 years), highlighting the need for vigilant monitoring.

Despite routine surveillance colonoscopy, nearly half of the cancers were diagnosed due to worsening symptoms rather than through dysplasia detection, raising concerns about the effectiveness of current surveillance strategies in preventing colorectal cancer in IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer in inflammatory bowel disease: a continuing problem. Mayer, R., Wong, WD., Rothenberger, DA., 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) 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]

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pmc.ncbi.nlm.nih.gov

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