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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Colonic Polyp, Colorectal Cancer, Adenoma Colon, Serrated Adenoma, Serrated Polyp

Intervention / Treatment
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* Device: GI-GENIUS Medtronic
* Other: Colonoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonoscopy assisted by GI-GENIUS<br> | Device: GI-GENIUS Medtronic<br>* Colonoscopy assisted by GI-GENIUS device<br>|
| Placebo Comparator: Standard colonoscopy<br> | Other: Colonoscopy<br>* Standard colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of advanced lesions | 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. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of other type of lesions | 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) | 15 months | 
| Characteristics of GI-GENIUS | 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. | 1 month |