Clinical trial NCT04964596: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Adenomatous Polyps
Keywords: Polyps detection
triage approach
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of detection of neoplastic colon polyp
timeFrame: 12 months
measure: Comparaison of neoplastic colon polyp number detected between CTC and colonoscopy
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Daniel von Renteln
role: PRINCIPAL_INVESTIGATOR
References: