Identifying gut microbiome biomarkers for early colorectal cancer screening in Portugal
Improving Colorectal Cancer Early Screening in Portugal: Identification and Validation of Biomarkers of Gut Microbiome in Stool
This study is trying to find specific gut bacteria in stool samples from people aged 40-74 in Lisbon to see if they can help detect early signs of colorectal cancer more accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30000 (estimated) |
| Ages | 40 Years to 74 Years |
| Sex | All |
| Sponsor | Gulbenkian Institute for Molecular Medicine Academic / other |
| Locations | 1 site (Lisbon, Lisbon District) |
| Trial ID | NCT06741293 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze stool samples from individuals aged 40-74 living in the Lisbon Metropolitan Area to identify gut microbiome biomarkers associated with early colorectal cancer (CRC) detection and the progression of precancerous lesions. Using advanced shotgun metagenomics, the researchers will correlate microbiome profiles with results from non-invasive tests like the Faecal Immunochemical Test (FIT) and colonoscopy. The ultimate goal is to develop a highly sensitive and non-invasive screening tool for CRC and high-risk adenomas, addressing the urgent need for improved early detection methods.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40-74 years residing in the Lisbon Metropolitan Area who can provide informed consent.
Not a fit: Patients under 40 or over 75 years old, those with a personal history of colorectal cancer, or those with certain severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and non-invasive screening methods for early detection of colorectal cancer, potentially saving lives.
How similar studies have performed: While the approach of using gut microbiome biomarkers for CRC detection is gaining interest, this specific study represents a novel application in the Portuguese context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide written informed consent and comply with study procedures * Reside in the Lisbon Metropolitan Area,, Portugal * Age from 40 to 74 years Exclusion Criteria: * Age \< 40 years or ≥ 75 years * Unable to provide informed consent * Refusal to provide stool samples * Active oncological disease * Personal history of CRC * Personal history of colon adenomas removed in the last 24 months * First-degree family history of CRC * Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, persistent and infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown aetiology or recurrent infection by Clostridioides difficile * Severe cardiovascular or heart diseases with medical diagnosis * Severe renal failure requiring hemodialysis * Severe lung disease * Pregnancy
Where this trial is running
Lisbon, Lisbon District
- Gulbenkian Institute for Molecular Medicine — Lisbon, Lisbon District, Portugal (Recruiting)
Study contacts
- Study coordinator: Ana S Almeida, PhD
- Email: ana.almeida@gimm.pt
- Phone: +351 217999411
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.