search
Back to results

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

Primary Purpose

Adenomatous Polyps

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
colonoscopy
FIT test
CT colonography
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenomatous Polyps focused on measuring Polyps detection, triage approach

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Montréal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

a colonoscopy as surveillance exam

undergoing a FIT as surveillance exam

undergoing CT colonography as surveillance exam

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of detection of neoplastic colon polyp
Number of patients with a neoplastic colon polyp detected during colonoscopy
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

Secondary Outcome Measures

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
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

Full Information

First Posted
July 9, 2021
Last Updated
November 23, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
search

1. Study Identification

Unique Protocol Identification Number
NCT04964596
Brief Title
Managing Colorectal Cancer Prevention Procedure Wait Lists During the COVID-19 Pandemic
Official Title
Managing Colorectal Cancer Prevention Procedure Wait Lists During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never started due to lack of staff
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
Keywords
Polyps detection, triage approach

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio into 3 groups
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a colonoscopy as surveillance exam
Arm Type
Active Comparator
Arm Description
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.
Arm Title
undergoing a FIT as surveillance exam
Arm Type
Active Comparator
Arm Description
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.
Arm Title
undergoing CT colonography as surveillance exam
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
colonoscopy
Intervention Description
colonoscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
FIT test
Intervention Description
faecal immunochemical test
Intervention Type
Diagnostic Test
Intervention Name(s)
CT colonography
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of detection of neoplastic colon polyp
Description
Number of patients with a neoplastic colon polyp detected during colonoscopy
Time Frame
12 months
Title
Comparaison of neoplastic colon polyp number detected between CTC and colonoscopy
Description
The number of neoplastic colon polyp detected with the CTC compare to the number of neoplastic colon polyp detected with colonoscopy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
12 months
Title
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
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel von Renteln
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montréal
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs