NCT06041945Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1800 (estimated)
- First submitted
- 4 Sept 2023
- Start date
- 21 Sept 2023
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Istituto Clinico Humanitas
- Diseases
- Colorectal cancer
- NCT number
- NCT06041945
What you commit to
- Study type: Interventional
- Planned participants: 1800
- From 21 Sept 2023 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with previous colonic resection.
- patients on antithrombotic therapy, precluding polyp resection.
Other illness
- patients with personal history of CRC, or IBD
- patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
Other
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
- patients who were not able or refused to give informed written consent.
Who the study is looking for
- All \>40 years-old patients undergoing colonoscopy for selected indications
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.