RecruitingNCT06741293

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


Sponsor

Gulbenkian Institute for Molecular Medicine

Enrollment

30,000 participants

Start Date

Nov 28, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 40 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study aims to identify gut bacteria (microbiome) patterns in stool that can be used as early markers for colorectal cancer in the Portuguese population. The goal is to develop a simple, non-invasive screening tool that could be used broadly to catch colorectal cancer earlier. **You may be eligible if...** - You are between 40 and 74 years old - You live in the Lisbon Metropolitan Area, Portugal - You are able to provide written consent and submit stool samples **You may NOT be eligible if...** - You are under 40 or 75 and older - You have an active cancer diagnosis - You have a personal or close family history of colorectal cancer - You have had colon adenomas (polyps) removed in the past 24 months - You have inflammatory bowel disease (such as Crohn's or ulcerative colitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention: observational study

No intervention: observational study


Locations(1)

Gulbenkian Institute for Molecular Medicine

Lisbon, Lisbon District, Portugal

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NCT06741293


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