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

Sponsor

Asociación Española de Gastroenterología (Other)

Overall Status

Completed

CT.gov ID

NCT04673136

Collaborator

Medtronic (Industry)

3,400

Enrollment

Locations

Arms

Actual Duration (Months)

566.7

Patients Per Site

47.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Colonic Polyp Colorectal Cancer Adenoma Colon Serrated Adenoma Serrated Polyp	Device: GI-GENIUS Medtronic Other: Colonoscopy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. Randomized Controlled Trial.

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Mar 31, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Colonoscopy assisted by GI-GENIUS	Device: GI-GENIUS Medtronic Colonoscopy assisted by GI-GENIUS device
Placebo Comparator: Standard colonoscopy	Other: Colonoscopy Standard colonoscopy

Arm

Intervention/Treatment

Experimental: Colonoscopy assisted by GI-GENIUS

Device: GI-GENIUS Medtronic

Colonoscopy assisted by GI-GENIUS device

Placebo Comparator: Standard colonoscopy

Other: Colonoscopy

Standard colonoscopy

Outcome Measures

Primary Outcome Measures

Detection of advanced lesions [15 months]
To determine the impact of the GI-GENIUS device as an assistant to the endoscopist to detect advanced lesions (advanced adenomas and advanced serrated polyps) in FIT-based screening colonoscopies.

Secondary Outcome Measures

Detection of other type of lesions [15 months]
To determine the ability of the GI-GENIUS device to detect other lesions (colorectal cancer, adenomas, advanced adenomas, serrated polyps, advanced serrated polyps, non-polypoid lesions ≥10mm and right-sided advanced adenomas)
Characteristics of GI-GENIUS [1 month]
To describe the characteristics of using the GI-GENIUS device during a colonoscopy: withdrawal time, false-positive and false-negative rate of advanced lesions using the device, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital General Universitario de Alicante	Alicante	Spain	03010
2	Hospital Clinic Barcelona	Barcelona	Spain
3	Complexo Hospitalario de Ourense	Ourense	Spain
4	Hospital Universitario Central de Asturias	Oviedo	Spain
5	Hospital Universitario Río Hortega	Valladolid	Spain
6	Hospital Universitario Álvaro Cunqueiro	Vigo	Spain