Clinical trial · Interventional
Artificial Intelligence-based Screening Models for Prevention and Early Detection of Colorectal Cancer
Definire Modelli di Screening Personalizzati, Basati Sull'Intelligenza Artificiale, Per la Prevenzione e la Diagnosi Precoce Del Cancro Del Colon-retto
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colorectal cancer screening is based on the fecal occult blood test (FIT), which has low sensitivity for adenomatous polyps, based on the currently used cut-off. Risk factors such as obesity, diabetes, alcohol, and cigarette smoking are associated with the presence of high-risk neoplasia in the screening population. CADe systems appear to increase ADR in screening programs; however, uncertainty remains regarding their true effectiveness. The study could provide the tools to: 1. devise a personalized pathway of CRC screening so as to refer to colonoscopy (with CAD or without CAD depending on the results that will be obtained) those at high risk of carrying neoplasms amenable to removal or curative treatment; 2. define risk categories for theoretical screening models giving the possibility of moving from the concept "one size fits all" to that of "personalized and precision prevention".
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonscope Olympus | Other | — | UNRESOLVED |
| GI Genius | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Colonoscopy using artificial intelligence (experimental group)
- description
- Colonoscopy using artificial intelligence
- interventionNames
- Device: GI Genius
- type
- OTHER
- label
- Traditional colonoscopy (control group)
- description
- Traditional colonoscopy
- interventionNames
- Other: Colonscope Olympus
Primary outcomes (1)
- measure
- To develop a predictive risk model useful in tailoring screening strategies for high-risk colorectal neoplasm (advanced adenoma/early stage cancer)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects aged 50-69 years who underwent the fecal occult blood screening program * Male and female sex * Positivity to fecal occult blood (FIT) on the immunochemical screening test (OC-Sensor);the cut-off for determination of test positivity is 20 micrograms HgB/gr of stool (cut-off used in our country). * Subjects who provided written consent to participate in the study. Exclusion Criteria: * Subjects who do not understand the Italian language * Subjects with previous history of total colectomy or bowel resections * Subjects with colonoscopy performed in the previous 12 months * Subjects with contraindications to colonoscopy * Subjects who have contraindication to sedation or anesthesia * Subjects with a personal history of CRC * Subjects with hereditary gastrointestinal cancer syndrome: familial adenomatous polyposis (FAP), attenuated FAP, MutYH-associated polyposis, Lynch or Lynch-like syndrome, and serratus polyposis syndrome. * Subjects with inflammatory bowel disease (Crohn's disease, ulcerative colitis).
References
Publications (0)
Data not yet available