A diagnostic tool using gut microbiome for colorectal cancer screening
A Gut Microbiome-based Diagnostic Tool for the Screening of Colorectal Cancer
This study is testing a new way to screen for colorectal cancer using gut bacteria samples from people aged 50-74 who have already had a positive result on a stool test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1202 (estimated) |
| Ages | 50 Years to 74 Years |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06738173 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50-74 who are part of the national CRC screening program and have a positive FIT result.
Not a fit: Patients who are unfit for colonoscopy or have other oncological conditions or severe gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could enhance early detection of colorectal cancer, leading to better patient outcomes and reduced mortality.
How similar studies have performed: While microbiome-based biomarkers for CRC screening are being explored, this specific approach is novel and has not been extensively tested in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome, RM
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.