NCT05355363 Risk of Metachronous Findings After Detection of Serrated Lesions and High-grade Dysplasia With Surveillance Delay
| NCT ID | NCT05355363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 730 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 730 participants in total. It began in 2023-02-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary aim of this study is to determine the rate of total metachronous advanced neoplasia (TMAN) detection after index detection of serrated lesions (SL) \[sessile serrated polyps (SSPs), traditional serrated adenomas (TSAs)\], and metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD). We will use the database of patients diagnosed with SL or HGD at index colonoscopy with a delay in surveillance and determine the risk of advanced lesions (especially high-risk lesion and CRC detection) of these delayed colonoscopies. The aim is to determine the effects of breach of continuity of care in these patients.
Eligibility 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.
Contact & Investigator
Daniel von Renteln, Md
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT05355363 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05355363 currently recruiting?
Yes, NCT05355363 is actively recruiting participants. Contact the research team at daniel.von.renteln.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT05355363 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05355363 clinical trial?
NCT05355363 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Daniel von Renteln, Md at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 730 participants.
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