Definire Modelli di Screening Personalizzati, Basati Sull'Intelligenza Artificiale, Per la Prevenzione e la Diagnosi Precoce Del Cancro Del Colon-retto

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 69
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Giovanni Barbara, MD
giovanni.barbara@unibo.it
+39 051 2142211
Backup
Chiara Pierantoni, MD
chiara.pierantoni@aosp.bo.it
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1400
Treatments
Experimental: Colonoscopy using artificial intelligence (experimental group)
Colonoscopy using artificial intelligence
Other: Traditional colonoscopy (control group)
Traditional colonoscopy
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov