Using AI to Improve Cost-Effectiveness of Colonoscopy Screening
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
This study is testing whether using artificial intelligence during colonoscopies can help doctors tell the difference between harmful and harmless polyps, making screening for colon cancer more effective and affordable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 2 sites (Rozzano, Milano and 1 other locations) |
| Trial ID | NCT06041945 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of artificial intelligence to assist in differentiating between neoplastic and non-neoplastic polyps during colonoscopy. It employs a randomized, multicenter approach with three parallel arms to evaluate the effectiveness of AI-assisted optical biopsy. The study aims to develop a deep learning algorithm that enhances personalized treatment and implements cost-saving strategies in colorectal cancer screening. Additionally, it will conduct cost-effectiveness analyses using real-world data to assess the impact of AI on screening programs.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old undergoing colonoscopy for specific indications.
Not a fit: Patients with a personal history of colorectal cancer, inflammatory bowel disease, or certain genetic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and cost-effective colonoscopy screenings, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for medical imaging and diagnostics, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rozzano, Milano and 1 other locations
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (Recruiting)
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Cesare Hassan
- Email: cesare.hassan@hunimed.eu
- Phone: 02-82247385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.