Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT06041945
Recruiting Not applicable

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

NCT06041945 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Clinico Humanitas
Phase
Not applicable
Started
2023-09-21
Last updated
2023-10-04

Condition(s) studied

Colonic Neoplasms

Investigational drug(s) / intervention(s)

Standard, high-definition colonoscopy with the use of CADe assistanceStandard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situStandard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ

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.

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.

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.

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Non-inferiority in Adenoma Detection Rate — 4 years
    Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.

Trial sites (2)

FacilityCityRegionStatus
Istituto Clinico Humanitas Rozzano Milano Recruiting
Istituto Clinico Humanitas Rozzano Milano Recruiting

More Istituto Clinico Humanitas trials in Italy

Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg (PATTERN) Active, not recruiting
Critical Illness Weakness Outside the Intensive Care Unit. Recruiting
Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes. Recruiting
Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA Recruiting
AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART) Active, not recruiting

Other trials for the same condition

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer Recruiting
Endoscopic Resection of Gastrointestinal Neoplasms Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06041945 on ClinicalTrials.gov ↗ ← All trials in Italy