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

NCT06799793 | Recruiting

• 2 other identifiers: DARE-SCR3PNC0000002
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Colorectal Cancer; Screening

Keywords

Artificial Intelligence (AI); Colorectal cancer (CRC)

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 18 months.

Study Arms (2)

Colonoscopy using artificial intelligence (experimental group)

EXPERIMENTAL

Colonoscopy using artificial intelligence

Device: GI Genius

Traditional colonoscopy (control group)

OTHER

Traditional colonoscopy

Other: Colonscope Olympus

Interventions

GI Genius DEVICE

GI 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).

Also known as: artificial intelligence

Colonoscopy using artificial intelligence (experimental group)

Colonscope Olympus OTHER

Colonoscopy with one of the Olympus colonoscopes supplied to the IRCCS AOUBO Gastroenterology Unit without the aid of the CAD system

Also known as: Colonscope

Traditional colonoscopy (control group)

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Giovanni Barbara, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Barbara, MD

CONTACT

+39 051 2142211; giovanni.barbara@unibo.it

Chiara Pierantoni, MD

CONTACT

chiara.pierantoni@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 29, 2025
• Study Start: December 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-10

Locations

IT (1)