Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting
GENIAL-CO
Resa Diagnostica Aggiuntiva Dell'Intelligenza Artificiale Nella Colonscopia (GENIAL COLONOSCOPY), Per lo Screening Del Carcinoma Colorettale
1 other identifier
interventional
900
1 country
1
Brief Summary
Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. The risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination. Artificial intelligence seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis. The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2020
CompletedFirst Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 10, 2025
December 1, 2023
3.5 years
June 9, 2020
April 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of advanced adenomas
The percentage of patients with adenomas with high-grade displasia in CADe colonoscopy group will be recorded and compared with the rate of patients with adenomas with high-grade displasia in standard colonoscopy group.
When available the histological report of polyps removed (up to 3 weeks).
Rate of patients detected with 3 or more adenomas.
The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group.
When available the histological report of polyps removed (up to 3 weeks).
Secondary Outcomes (9)
Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas.
When available the histological report of polyps removed (up to 3 weeks).
Size of lesions detected
Immediately after the procedure.
Rate of neoplasia by colonic site
Immediately after the procedure.
Post-colonoscopy surveilance
When available the histological report of polyps removed (up to 3 weeks).
Time of cecal intubation.
Immediately after the procedure.
- +4 more secondary outcomes
Study Arms (2)
Artificial intelligence arm
EXPERIMENTALPatients undergoing colonoscopy with artificial intelligence.
standard colonoscopy arm
ACTIVE COMPARATORPatients undergoing colonoscopy with standard colonscopy
Interventions
We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a FIT-positive screening population.
Eligibility Criteria
You may qualify if:
- Patients aged 50 to 69 undergoing colonoscopy examination following a positive fecal immunochemical test (FIT) performed in the context of a regional mass-screening program.
You may not qualify if:
- Patients unwilling or unable to give informed consent.
- Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Related Publications (1)
Spada C, Cesaro P, Fuccio L, Salvi D, Ferrari C, Barbaro F, Bizzotto A, Butitta F, Gerardi V, Lovera M, Milluzzo SM, Minelli Grazioli L, Olivari N, Pecere S, Piccirelli S, Pugliano CL, Pesatori EV, Quadarella A, Tettoni E, Zani C, Ricciardiello L, Costamagna G. Impact of Artificial Intelligence for Detection of Precancerous Colonic Lesions in a Fecal Immunochemical Blood Test-Based Organized Screening Program in Italy: A Randomized Control Trial. United European Gastroenterol J. 2026 Feb;14(1):e70176. doi: 10.1002/ueg2.70176.
PMID: 41563802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristiano Spada, MD, PhD
Fondazione Poliambulanza Istituto Ospedaliero
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 22, 2020
Study Start
May 4, 2020
Primary Completion
October 31, 2023
Study Completion
December 31, 2023
Last Updated
April 10, 2025
Record last verified: 2023-12