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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-03-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Colonoscopy assisted by GI-GENIUS

Group Type EXPERIMENTAL

GI-GENIUS Medtronic

Intervention Type DEVICE

Colonoscopy assisted by GI-GENIUS device

Standard colonoscopy

Group Type PLACEBO_COMPARATOR

Colonoscopy

Intervention Type OTHER

Standard colonoscopy

Interventions

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GI-GENIUS Medtronic

Colonoscopy assisted by GI-GENIUS device

Intervention Type DEVICE

Colonoscopy

Standard colonoscopy

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes