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Completed

NCT Number: NCT04673136

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

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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Key information

Conditions

Colorectal Neoplasms Adenoma Colon Colonic Diseases Colonic Polyp Colonic Polyps Colorectal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases Serrated Adenoma Serrated Polyp

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario de Alicante, Alicante, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GI-GENIUS Medtronic

Device

Colonoscopy assisted by GI-GENIUS device

colonoscopy

Other

Standard colonoscopy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Asociación Española de Gastroenterología

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: CADILLAC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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