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Recruiting NCT06041945

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

No phase Interventional Colonic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard, high-definition colonoscopy with the use of CADe assistance, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ.
Who it may be relevant to
Registry conditions: Colonic Neoplasms. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Non-inferiority in Adenoma Detection Rate [Time frame: 4 years]
Secondary outcome measures (3)
  • Negative Predictive Value for colorectal neoplasia [Time frame: 4 years]
  • Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy [Time frame: 4 years]
  • Change in the cost of polypectomy and histology in screening programs [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

  • All >40 years-old patients undergoing colonoscopy for selected indications

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Italy · 2 centers
  • Istituto Clinico Humanitas — Rozzano
  • Istituto Clinico Humanitas — Rozzano

Identifiers

NCT: NCT06041945 · 3483 - SAVE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗