Actively Recruiting

Phase Not Applicable
Age: 50Years - 69Years
All Genders
NCT06799793

Artificial Intelligence-based Screening Models for Prevention and Early Detection of Colorectal Cancer

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-29

1400

Participants Needed

1

Research Sites

108 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Artificial Intelligence-based Screening Models for Prevention and Early Detection of Colorectal Cancer

Who Can Participate

Age: 50Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects aged 50-69 years who underwent the fecal occult blood screening program
  • Male and female sex
  • Positive fecal occult blood test (FIT) with a cut-off of 20 micrograms HgB/g of stool
  • Provided written consent to participate in the study
Not Eligible

You will not qualify if you...

  • Subjects who do not understand the Italian language
  • Previous total colectomy or bowel resections
  • Colonoscopy performed in the previous 12 months
  • Contraindications to colonoscopy
  • Contraindications to sedation or anesthesia
  • Personal history of colorectal cancer
  • Hereditary gastrointestinal cancer syndromes including familial adenomatous polyposis (FAP), attenuated FAP, MutYH-associated polyposis, Lynch or Lynch-like syndrome, and serrated polyposis syndrome
  • Inflammatory bowel disease such as Crohn's disease or ulcerative colitis

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

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Research Team

G

Giovanni Barbara, MD

CONTACT

C

Chiara Pierantoni, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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