Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. (CADILLAC)

Asociación Española de Gastroenterología

Status

Completed

Conditions

Colonic Polyp

Intestinal Neoplasms

Serrated Adenoma

Serrated Polyp

Colorectal Neoplasms

Gastrointestinal Neoplasms

Adenoma Colon

Colorectal Cancer

Treatments

Device: GI-GENIUS Medtronic

Other: Colonoscopy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04673136

CADILLAC-01

Details and patient eligibility

About

Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas.

Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect.

The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy.

If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.

Enrollment

3,400 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Individuals with a positive result in fecal immunochemical test within the population-based colorectal cancer screening program.
Complete colonoscopy with cecal intubation.
Inform consent signed.

Exclusion criteria

Personal history of colorectal cancer.
Family history of colorectal cancer: ≥2 FDR or ≥1 FDR diagnosed before 50 years of age.
Family history of hereditary colorectal cancer syndromes: Lynch syndrome, FAP, etc.
Personal history of inflammatory bowel disease.
Terminal illness.
Personal history of total proctocolectomy.