Recruiting

Observational Study

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05355363

Conditions

Colorectal Cancer

Colon Adenoma

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard Colonoscopy

Study Details

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

Study ID

NCT05355363

Start date

Feb 27, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

730 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Colonoscopy

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

Interventions

Standard Colonoscopy

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

Primary outcome measure

  • Rate of TMAN detection after index detection of serrated lesions [ Time Frame: 1 year ]
  • Rate of metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Daniel von Renteln, MD, PhD

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

Julie Fleury

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

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada

Contacts

Julie Fleury

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

Principal Investigator:

Daniel Von Renteln, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 11, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-02-11.