Managing Colorectal Cancer Prevention Procedure Wait Lists During the COVID-19 Pandemic

The main objective of this study is to offer and evaluate an interim triage approach for patients waiting for surveillance colonoscopies. This will reduce the waiting period and the psychological stressors for our patients and from a scientific point of view allow us to compare the yield of findings for each approach.

Study Overview

• Status: Withdrawn
• Conditions: Adenomatous Polyps
• Intervention / Treatment: Diagnostic test: colonoscopy; Diagnostic test: FIT test; Diagnostic test: CT colonography

Detailed Description

This study will randomize patients (with low-risk findings in the initial colonoscopy) waiting for a surveillance colonoscopy into a follow-up with either FIT, CT colonography or colonoscopy. This approach will speed up the time for an exam for our patients and allow us to gather important data on the yield of significant findings when using FIT vs CT colonography vs colonoscopy for the surveillance exam.

All patients with positive FIT or CT colonography results will undergo subsequent colonoscopy. 300 patients will be randomized to 1:1:1 into 3 groups:

Group 1: patients will undergo Colonoscopy, findings will be documented and their participation in the study will end there. The findings of the colonoscopy will be addressed according to the institution's guidelines.

Group 2 will undergo fit testing if the fit test is positive: patients will have a subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. The findings of the colonoscopy will be addressed according to our institution's guidelines. If Fit test is negative patient will leave the study and will have a follow-up colonoscopy in one year.

Group 3 will have CT colonography. If CTC is positive: patients will have a subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. The findings of the colonoscopy will be addressed according to our institution's guidelines. If CTC is negative for polypoid lesions, the patient will leave the study and will have a follow-up 5 years after with a control colonoscopy.

All CT colonography and FIT tests analysis for patients will be performed as per the standard of care. Patients with suspicious lesions in CT colonography and positive FIT results will be redirected for colonoscopy and prioritized as P3 (Meaning endoscopy has to be done within 3 months).

Polypectomy specimens will be sent for pathological examination according to the standard of care and institutional routine practice. Pathology results will be followed up.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Centre hospitalier universitaire de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- people with referral sheets for surveillance colonoscopies : meaning 3 or 5 years after the initial colonoscopy.

Exclusion Criteria:

• known or suspected acute diverticulitis
• ulcerative colitis
• Crohn's disease
• toxic megacolon
• acute abdominal pain
• familial polyposis syndrome
• coagulopathy
• poor general health (defined as an American Society of Anaesthesiologists class >3)
• patients presenting for emergency colonoscopies
• patients incapable of lying flat on their back for the duration of the CT colonography due CHF or other predispositions
• patients with a personal history of CRC
• patient undergoing colonoscopy for surveillance after EMR or ESD procedures
• patients diagnosed with a CRC or a metastatic cancer
• patients with a history of contrast allergies
• Patients referred for polypectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: a colonoscopy as surveillance exam; patients will undergo Colonoscopy, finding will be documented. Findings of colonoscopy will be documented and treated according to the institutional standards. Study participation for patients ends after the colonoscopy and follow-up of pathology results and complication assessment.	Diagnostic test: colonoscopy; colonoscopy
Active Comparator: undergoing a FIT as surveillance exam; if the FIT test is positive: patients will have subsequent colonoscopy within 3 months. Findings of FIT testing and if positive the colonoscopy will be documented and participation in the study will end after that. Findings of the FIT test and colonoscopy will be treated according to the institutional standards. If FIT test is negative patient will leave the study and will have a follow up with a colonoscopy or FIT test in 1 to 2 years outside of this study.	Diagnostic test: FIT test; faecal immunochemical test
Active Comparator: undergoing CT colonography as surveillance exam; If CTC is positive: patients will have subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. Findings of the colonoscopy will be addressed according to our institution's guidelines. If CTC is negative for polypoid lesions patient will leave the study and will have a follow up 5 years after with either a CTC or colonoscopy.	Diagnostic test: CT colonography; noninvasive medical imaging technique that uses computed tomography to visualize the interior of the colon and rectum especially to screen for polyps or cancerous growths

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of detection of neoplastic colon polyp	Number of patients with a neoplastic colon polyp detected during colonoscopy	12 months
Comparaison of neoplastic colon polyp number detected between CTC and colonoscopy	The number of neoplastic colon polyp detected with the CTC compare to the number of neoplastic colon polyp detected with colonoscopy	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients on the list having a positive or negative FIT test or CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy	Number of patients on the list having a positive or negative FIT test or CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy	12 months
Number of patients on the list having a CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy	Number of patients on the list having a CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Polyps detection; triage approach
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms, Glandular and Epithelial; Adenoma; COVID-19; Adenomatous Polyps
• Other Study ID Numbers: 21.210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No