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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1) Patients with a diagnosis of inflammatory bowel disease;

2) Hereditary CRC syndromes;

3) CRC at index colonoscopy;

4) Serrated polyposis syndrome;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

730 Participants
are divided into 1 treatment group
Group A: ColonoscopyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 \[sessile serrated polyps (SSPs), traditional serrated adenomas (TSAs)\]

Time frame
1 year
2

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)

Time frame
1 year

Secondary outcomes

1

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

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

Time frame
1 year
2

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

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

Time frame
1 year
3

Rate of metachronous HRA detection for index HGD alone

The rate of metachronous HRA detection for index HGD alone

Time frame
1 year
4

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

The rate of metachronous HRA detection for index HGD according to number, size, location, of index HGD

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.