About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
GI Genius
DeviceGI Genius software component is an artificial intelligence-based medical device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions such as polyps, including those with flat morphology (nonpolyp).
Colonscope Olympus
Other interventionColonoscopy with one of the Olympus colonoscopes supplied to the IRCCS AOUBO Gastroenterology Unit without the aid of the CAD system
Treatment groups
Trial outcomes
Primary outcomes
To develop a predictive risk model useful in tailoring screening strategies for high-risk colorectal neoplasm (advanced adenoma/early stage cancer)
Adenoma Detection Rate (ADR, percentage of patients screened with at least 1 adenoma or carcinoma histologically proven) assessed following endoscopic examination and post-collection histopathological result in relation to risk factors.
Sponsors and contacts
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