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Search / Trial NCT06799793

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

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 28, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Artificial Intelligence (Ai) Colorectal Cancer (Crc)

ClinConnect Summary

This clinical trial is studying new ways to screen for colorectal cancer, which is a type of cancer that affects the large intestine. Currently, the standard screening method is a test called the fecal occult blood test (FIT), but it doesn’t always detect early signs of cancer effectively. Researchers are exploring how artificial intelligence (AI) can help improve these screening methods and create personalized screening plans. This means that instead of using a general approach for everyone, the trial aims to identify specific risk factors—like obesity and diabetes—to better target those who may need further testing, such as a colonoscopy.

To be eligible for the trial, participants need to be between 50 and 69 years old and must have tested positive for blood in their stool using the FIT test. They also need to understand Italian and provide consent to join the study. Those with certain medical histories, like previous bowel surgeries or specific hereditary cancer syndromes, are not eligible. Participants can expect to receive a more tailored approach to screening, which could lead to earlier detection and treatment of colorectal cancer. This trial is currently recruiting and is important for improving how we detect and prevent colorectal cancer in the future.

Gender

ALL

Eligibility criteria

  • 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).

About Irccs Azienda Ospedaliero Universitaria Di Bologna

IRCCS Azienda Ospedaliero-Universitaria di Bologna is a prestigious research and healthcare institution in Italy, renowned for its commitment to advancing medical science and patient care through innovative clinical research. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it integrates clinical practice with scientific research, facilitating the translation of laboratory findings into effective treatment strategies. The institution fosters a multidisciplinary approach, collaborating with various experts to conduct high-quality clinical trials aimed at improving health outcomes across a wide range of medical fields. With a strong emphasis on ethical standards and patient welfare, IRCCS Azienda Ospedaliero-Universitaria di Bologna plays a vital role in shaping the future of medicine through rigorous scientific inquiry and patient-centered care.

Locations

Bologna, , Italy

Patients applied

0 patients applied

Trial Officials

Giovanni Barbara, MD

Principal Investigator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported