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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-74
SponsorGulbenkian Institute for Molecular Medicine

About this trial

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 criteria

Qualifiers

Ability to provide written informed consent and comply with study procedures

Reside in the Lisbon Metropolitan Area,, Portugal

Age from 40 to 74 years

Disqualifiers

Age < 40 years or ≥ 75 years

Unable to provide informed consent

Refusal to provide stool samples

Active oncological disease

Trial design

Treatments tested in this trial

  • No intervention: observational study

Treatment groups

30,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Gulbenkian Institute for Molecular Medicine

Lead sponsor

Hospital CUF Descobertas, Lisbon, Portugal

Collaborator

CUF Tejo Hospital

Collaborator

Hospital da Luz Lisboa, Portugal

Collaborator