RecruitingNot ApplicableNCT06041945

Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

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


Sponsor

Istituto Clinico Humanitas

Enrollment

1,800 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether an AI tool can accurately predict polyp type during colonoscopy (while looking at it live), which could reduce the need for unnecessary follow-up procedures. **You may be eligible if...** - You are over 40 years old - You are having a colonoscopy for a clinical reason (screening, surveillance, or symptoms) **You may NOT be eligible if...** - You have a personal history of colorectal cancer or inflammatory bowel disease - You have Lynch syndrome or Familial Adenomatous Polyposis - Your bowel preparation was poor - You have had prior colon surgery - You are on blood-thinning therapy that prevents polyp removal - You are unable or unwilling to give written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStandard, high-definition colonoscopy with the use of CADe assistance

All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.

DEVICEStandard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ

All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.

DEVICEStandard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ

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.


Locations(2)

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

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NCT06041945


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