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

NCT04964596 | Withdrawn

• 1 other identifier: 21.210
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomatous Polyps

Keywords

Polyps detection; triage approach

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

  12 months

Study Arms (3)

a colonoscopy as surveillance exam

ACTIVE COMPARATOR

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

undergoing a FIT as surveillance exam

ACTIVE COMPARATOR

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

undergoing CT colonography as surveillance exam

ACTIVE COMPARATOR

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

Interventions

colonoscopy DIAGNOSTIC_TEST

colonoscopy

a colonoscopy as surveillance exam

FIT test DIAGNOSTIC_TEST

faecal immunochemical test

undergoing a FIT as surveillance exam

CT colonography DIAGNOSTIC_TEST

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

undergoing CT colonography as surveillance exam

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Adenomatous Polyps

Interventions

Colonoscopy; Colonography, Computed Tomographic

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray

Study Officials

• Daniel von Renteln

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 16, 2021
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CA (1)