Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years. (IA-COLO 2)

University Hospital of Bordeaux

Status: Begins enrollment this month

Conditions: Intestinal Polyps; Colorectal Neoplasms; Colonoscopy

Treatments: Procedure: Colonoscopy CADe; Procedure: Standard colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07299071

CHUBX 2024/48

Details and patient eligibility

About

The occurrence of interval cancers after colonoscopy raises the possibility of missed lesions. High- performance computer aided diagnosis (CAD) systems have been specially designed for the detection of colorectal lesions (CAD for detection is named CADe). The use of CADe improves adenoma detection in screening colonoscopy. The potential of CADe system in reducing the rate of progression to advanced polyps or interval cancer between two colonoscopies remains still uncertain.

Full description

Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Randomization into two groups: standard colonoscopy vs. colonoscopy with CADe (CAD EYE or GENIUS) (1:1). A follow-up consultation will be scheduled one-month postcolonoscopy for delivery of histological results and then at 3 years in order to organize the next colonoscopy. As part of the study, a new control colonoscopy will be scheduled for patients with high risk of CRC at 3 years. The 3-year control colonoscopy will be performed with the CAD system for all patients. The colonoscopy will be performed by another investigator who does not know the results nor the type of the first colonoscopy (evaluator blinded). In the low-risk group, we will collect follow-up data as part of routine care, including the results of colonoscopies performed outside of the protocol

Enrollment: 592 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age with indication for colonoscopy as part of a screening program, after a positive immunological (FIT) test, and/or for personal or family history of colorectal cancer and/or personal history of colonic adenomas,
• Written informed consent signed
• Patients covered by a health-care insurance.

Exclusion criteria

• Failed complete colonoscopy, defined by the absence of cecal intubation and/or the absence of terminal ileum cauterization
• Inadequate bowel preparation (Boston bowel preparation score < 6, and/or least at one part of colon with score ≤ 1)
• An infiltrative tumor was diagnosed during colonoscope insertion time, not accessible to endoscopic resection and likely to require surgical management (a procedure where part of the colon may need to be removed).
• Patient under guardianship or protection
• Pregnant women
• Not fluent in French or illiterate
• Personal history of inflammatory bowel disease
• Personal history of genetic predisposition of CRC
• Personal history of colonic surgery

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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592 participants in 2 patient groups, including a placebo group

Standard colonoscopy

Placebo Comparator group

Description:

Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has standard colonoscopy

Treatment:

Procedure: Standard colonoscopy

Colonoscopy with CADe

Active Comparator group

Description:

Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has colonoscopy with CADe (CAD EYE or GENIUS)

Treatment:

Procedure: Colonoscopy CADe