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

April 7, 2022 updated by: Asociación Española de Gastroenterología

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital Clínic Barcelona
      • Ourense, Spain
        • Complexo Hospitalario de Ourense
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Valladolid, Spain
        • Hospital Universitario Río Hortega
      • Vigo, Spain
        • Hospital Universitario Alvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación Española de Gastroenterología

Collaborators

Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

March 31, 2022

Study Completion (ACTUAL)

March 31, 2022

Study Registration Dates

First Submitted

December 13, 2020

First Submitted That Met QC Criteria

December 13, 2020

First Posted (ACTUAL)

December 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CADILLAC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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