Identifying gut microbiome biomarkers for early colorectal cancer screening in Portugal

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.