MedTrace Logo

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

NCT06041945 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Colonic Neoplasms

Interventions

DEVICE

Standard, 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.

DEVICE

Standard, 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.

DEVICE

Standard, 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.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06041945 on ClinicalTrials.gov