MedTrace Logo

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

NCT06741293 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30000

Last updated 2026-05-14

No results posted yet for this 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.

Conditions

  • Colorectal Cancer Screening
  • Colorectal Cancer (CRC)
  • Microbiome

Interventions

OTHER

No intervention: observational study

No intervention: observational study

Sponsors & Collaborators

  • Hospital CUF Descobertas, Lisbon, Portugal

    collaborator UNKNOWN

  • CUF Tejo Hospital

    collaborator UNKNOWN

  • Hospital da Luz Lisboa, Portugal

    collaborator UNKNOWN

  • Gulbenkian Institute for Molecular Medicine

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2026-11-28
Completion
2029-11-28

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06741293 on ClinicalTrials.gov