Risk of Metachronous Findings After Detection of Serrated Lesions and High-grade Dysplasia With Surveillance Delay

NCT05355363 | Recruiting

• 1 other identifier: 22.179
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colon Adenoma

Keywords

sessile serrated polyps; traditional serrated adenomas; high-grade dysplasia; high-risk adenoma; cancer prevention; Colonoscopy

Outcome Measures

Primary Outcomes (2)

• Rate of TMAN detection after index detection of serrated lesions

  the rate of total metachronous advanced neoplasia (TMAN) detection after index detection of serrated lesions \[sessile serrated polyps (SSPs), traditional serrated adenomas (TSAs)\]

  1 year

• Rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD)

  the rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD)

  1 year

Secondary Outcomes (11)

• Rate of T-MAN detection for concomitant index SSP+low-risk adenoma (LRA); index SSP+ high-risk adenoma (HRA); index SSP alone

  1 year

• Rate of T-MAN detection according to number, size, location, and dysplasia status of index SSPs

  1 year

• Rate of metachronous HRA detection for index HGD alone

  1 year

• Rate of metachronous HRA detection for index HGD according to number, size, location, of index HGD

  1 year

• Rate of metachronous high-risk serrated lesion (SL) for concomitant index SSP+LRA; index SSP+HRA; index SSP alone; index SSP all synchronous findings included; index TSA a ll synchronous findings included

  1 year

Study Arms (1)

Colonoscopy

EXPERIMENTAL

Standard colonoscopy: All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.

Diagnostic Test: Standard Colonoscopy

Interventions

Standard Colonoscopy DIAGNOSTIC_TEST

Standard colonoscopy: All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.

Colonoscopy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) Patients with a diagnosis of inflammatory bowel disease;
• \) Hereditary CRC syndromes;
• \) CRC at index colonoscopy;
• \) Serrated polyposis syndrome;
• \) Life expectancy too short to benefit from colonoscopy;
• \) 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Daniel von Renteln, Md

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel von Renteln, MD, PhD

CONTACT

514-890-8000; daniel.von.renteln.med@ssss.gouv.qc.ca

Julie Fleury

CONTACT

514-890-8000; julie.fleury.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, multi-endoscopist, single center, single group assignment

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: May 2, 2022
• Study Start: February 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)