Assessing the risk of advanced colorectal lesions after delayed surveillance for serrated lesions and high-grade dysplasia
Risk of Metachronous Findings After Detection of Serrated Lesions and High-grade Dysplasia With Surveillance Delay
This study is trying to see if waiting too long for follow-up colonoscopies after finding certain types of polyps increases the risk of developing serious colorectal problems like cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 730 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05355363 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the rate of total metachronous advanced neoplasia detection following the identification of serrated lesions and high-grade dysplasia during colonoscopy. By analyzing a database of patients diagnosed with these conditions between 2010 and 2022, the research will investigate the implications of delayed surveillance on the development of advanced lesions, including high-risk adenomas and colorectal cancer. The study seeks to clarify the optimal timing for follow-up colonoscopies based on current guidelines and the actual risk of progression in these patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45-80 who have undergone colonoscopy and had serrated lesions or high-grade dysplasia detected without appropriate follow-up.
Not a fit: Patients with inflammatory bowel disease, hereditary colorectal cancer syndromes, or those diagnosed with colorectal cancer at index colonoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surveillance recommendations, potentially reducing the risk of colorectal cancer in patients with serrated lesions and high-grade dysplasia.
How similar studies have performed: While there is limited literature on the optimal surveillance intervals for serrated lesions, this study addresses a gap in existing research, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 45-80 who underwent colonoscopy from 2009 to 2022 at the Montreal University Hospital Center (CHUM) with 1+ SL or HGD detected at index colonoscopy and lacking follow-up within or beyond the surveillance interval recommended by 2020 USMSTF guidelines. Exclusion Criteria: * 1\) Patients with a diagnosis of inflammatory bowel disease; * 2\) Hereditary CRC syndromes; * 3\) CRC at index colonoscopy; * 4\) Serrated polyposis syndrome; * 5\) Life expectancy too short to benefit from colonoscopy; * 6\) Follow-up colonoscopy not yet due according to USMSTF guidelines. Patients with concomitant HRA and SL at index will be invited to participate if the index (or last) colonoscopy was performed more than 1 year ago. This is based on the high rates of HRA we identified in our retrospective study posing increased risks for these patients.
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel von Renteln, Md — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Daniel von Renteln, MD, PhD
- Email: daniel.von.renteln.med@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.