Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
SAVE
Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
1 other identifier
interventional
1,800
1 country
2
Brief Summary
This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
September 4, 2023
CompletedFirst Posted
Study publicly available on registry
September 18, 2023
CompletedStudy Start
First participant enrolled
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
October 4, 2023
September 1, 2023
3.9 years
September 4, 2023
October 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Non-inferiority in Adenoma Detection Rate
Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.
4 years
Secondary Outcomes (3)
Negative Predictive Value for colorectal neoplasia
4 years
Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy
4 years
Change in the cost of polypectomy and histology in screening programs
4 years
Study Arms (3)
Standard Arm CADe
ACTIVE COMPARATORStandard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
Standard Arm CADe/CADx
ACTIVE COMPARATORStandard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
Leave-In-Situ Arm
EXPERIMENTALStandard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC). Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.
Interventions
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.
Eligibility Criteria
You may qualify if:
- All \>40 years-old patients undergoing colonoscopy for selected indications
You may not qualify if:
- patients with personal history of CRC, or IBD
- patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
- patients with previous colonic resection.
- patients on antithrombotic therapy, precluding polyp resection.
- patients who were not able or refused to give informed written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2023
First Posted
September 18, 2023
Study Start
September 21, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
October 4, 2023
Record last verified: 2023-09