NCT06741293Recruiting
Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)
Improving Colorectal Cancer Early Screening in Portugal: Identification and Validation of Biomarkers of Gut Microbiome in Stool
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
Colorectal cancer (CRC) is a major public health problem, responsible for 2 million new cases and almost 1 million deaths annually worldwide. In Portugal, as of 2022, CRC is the most common cancer, with 10,575 new cases reported, and the second leading cause of cancer-related mortality, accounting for 4,809 deaths (approximately 14% of all cancer-related deaths). In recent years, there has been an alarming increase in the incidence and mortality of CRC in people \<50 years of age. Early detection is crucial, as survival rates decline sharply from 90% when detected early to just 10% in advanced stages. Non-invasive diagnostic tests, such as the Faecal Immunochemical Test (FIT), have a low sensitivity for early-stage lesions and a high rate of false positives. Therefore, there is an urgent need to improve non-invasive diagnostic methods for the early detection of CRC, as effective screening can prevent it by detecting and removing premalignant lesions. Recent studies suggest that an altered gut microbiota may confer susceptibility to certain types of cancer. Interestingly, the gut microbiota of patients with adenomas or CRC differs from that of healthy individuals. This study aims to identify gut microbiome biomarkers in faecal samples associated with CRC and/or high-risk adenomas to improve early detection.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30000 (estimated)
- First submitted
- 10 Dec 2024
- Start date
- 28 Nov 2023
- Primary completion date
- 28 Nov 2026
- Lead sponsor
- Gulbenkian Institute for Molecular Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT06741293
What you commit to
- Study type: Observational
- Planned participants: 30000
- From 28 Nov 2023 to the primary completion date, 28 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active oncological disease
- Personal history of CRC
- Personal history of colon adenomas removed in the last 24 months
- First-degree family history of CRC
- Severe cardiovascular or heart diseases with medical diagnosis
- Severe renal failure requiring hemodialysis
- Severe lung disease
Age
- Age \< 40 years or ≥ 75 years
Other
- Unable to provide informed consent
- Refusal to provide stool samples
- Pregnancy
Who the study is looking for
- Ability to provide written informed consent and comply with study procedures
- Reside in the Lisbon Metropolitan Area,, Portugal
- Age from 40 to 74 years
Age in the registry: 40 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gulbenkian Institute for Molecular Medicine Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.