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

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.

NCT Number	NCT06741293
Lead Sponsor	Gulbenkian Institute for Molecular Medicine Collaborators: Hospital CUF Descobertas, Lisbon, Portugal, CUF Tejo Hospital, Hospital da Luz Lisboa, Portugal
Conditions	Colorectal Cancer Screening, Colorectal Cancer (CRC), Microbiome
Enrollment	30,000 participants
Start Date	2023-11-28
Primary Completion	2026-11-28 (estimated)
Study Completion	2029-11-28 (estimated)
Updated on ClinicalTrials.gov	2026-05-14