A diagnostic tool using gut microbiome for colorectal cancer screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop a gut microbiome-based diagnostic tool to identify colorectal cancer (CRC) and advanced colorectal adenomas. It focuses on patients aged 50-74 who are participating in the national CRC screening program and have tested positive for fecal immunochemical testing (FIT). The study will analyze alterations in the gut microbiome and specific microbial signatures that may indicate the presence of CRC. By identifying non-invasive biomarkers, the study seeks to improve the diagnostic yield and reduce unnecessary colonoscopies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients participating in the national CRC screening program (50-74 years old)
* Positivity to the FIT;
* Ability to provide written informed consent and to be compliant with the study procedures.

Exclusion Criteria:

* Patients unfit for colonoscopy;
* Other oncological conditions;
* Concomitant severe comorbidities or gastrointestinal (GI) organic diseases (e.g. diverticular disease, inflammatory bowel disease);
* Antibiotics, proton pump inhibitors or probiotics within 4 weeks prior to enrollment.

Where it's running

• Catholic University of the Sacred Heart
  Rome, Rm, Italy Recruiting

Study contacts

• Study coordinator: Gianluca Ianiro, MD, PhD
• Email: gianluca.ianiro@unicatt.it
• Phone: 0630159539

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.