Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
Healthy Volunteers
NCT06041945

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

Led by Istituto Clinico Humanitas · Updated on 2023-10-04

1800

Participants Needed

2

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients aged over 40 years undergoing colonoscopy for selected reasons
Not Eligible

You will not qualify if you...

  • Personal history of colorectal cancer or inflammatory bowel disease
  • Diagnosis of Lynch syndrome or Familial Adenomatous Polyposis
  • Inadequate bowel preparation (Boston Bowel Preparation Scale less than 2 in any colon segment)
  • Previous colon surgery
  • Use of antithrombotic therapy preventing polyp removal
  • Unable or unwilling to provide written informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Istituto Clinico Humanitas

Rozzano, Milano, Italy, 20089

Actively Recruiting

2

Istituto Clinico Humanitas

Rozzano, Milano, Italy, 20089

Actively Recruiting

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Research Team

C

Cesare Hassan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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