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Clinical Trials in Portugal / NCT06741293
Recruiting Observational

Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)

NCT06741293 · tracked via the Priya Life Science Portugal tracker
Sponsor
Gulbenkian Institute for Molecular Medicine
Phase
Observational
Started
2023-11-28
Last updated
2026-05-14

Condition(s) studied

Colorectal Cancer ScreeningColorectal Cancer (CRC)Microbiome

Investigational drug(s) / intervention(s)

No intervention: observational study

No intervention: observational study: No intervention: observational study

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
74 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Microbiome biomarkers associated with CRC and/or high-risk polyps. — Baseline and Follow-up every 2 years up to 6 years
    The faecal microbiota composition and gene profiles will be analysed using shotgun metagenomic sequencing on a subset of participants (up to 10,000 samples). Data will be integrated with lifestyle, dietary factors and colonoscopy results to identify biomarkers linked to CRC and adenomas.
  • Correlation between microbiome biomarkers and FIT results — Baseline and Follow-up every 2 years up to 6 years
    Faecal microbiome analysis results will be compared with FIT test results to evaluate the predictive value, negative predictive value, and overall effectiveness in detecting CRC in an asymptomatic population.

Trial sites (1)

FacilityCityRegionStatus
Gulbenkian Institute for Molecular Medicine Lisbon Lisbon District Recruiting

More Gulbenkian Institute for Molecular Medicine trials in Portugal

CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer Recruiting
AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing Recruiting

Other trials for the same condition

CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06741293 on ClinicalTrials.gov ↗ ← All trials in Portugal