Actively Recruiting
Saving by Artificial Intelligence for Virtual Endoscopy Biopsy 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of artificial intelligence (AI) to improve colonoscopy screening for colorectal polyps, aiming to distinguish between cancerous (neoplastic) and non-cancerous (non-neoplastic) polyps. This trial, conducted at multiple centers with three parallel groups, will also assess cost-saving strategies by using AI-assisted optical biopsy and develop new AI tools to better identify cancer risk regardless of the physician's skill. The study includes a cost-effectiveness analysis using real-world data and advanced trial emulation methods. Participants will undergo high-definition colonoscopy with one of three approaches: standard colonoscopy assisted by AI detection (CADe), colonoscopy assisted by both AI detection and diagnosis (CADe/CADx) with all polyps removed, or colonoscopy assisted by AI detection and diagnosis where certain small polyps in specific locations may be left in place if judged to be harmless. All removed polyps will be examined by pathology. The trial compares these approaches to find the best balance between accurate diagnosis and cost savings. During the study, participants will be monitored over four years to measure outcomes such as the adenoma detection rate, the accuracy of ruling out colorectal neoplasia, the agreement between surveillance plans based on polyp removal versus leaving some polyps in place, and the impact on costs related to polyp removal and pathology. This long-term follow-up includes assessments at regular intervals to evaluate effectiveness and safety, contributing to improved personalized colorectal cancer screening.
CONDITIONS
Brief Title
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 years or older undergoing colonoscopy for selected indications
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 blood thinning medications that prevent polyp removal
- Unable or unwilling to provide informed written consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo standard, high-definition colonoscopy using artificial intelligence-assisted devices to detect and manage polyps according to their assigned strategy.
1 procedure visit (in-person)
Duration - Up to 4 years
Participants are monitored for outcomes related to adenoma detection rates and cost-saving strategies over time.
Follow-up visits as scheduled per screening program
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
Research Team
C
Cesare Hassan
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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