Gut Microbiome Testing for Colorectal Cancer Screening
Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)
Recruiting
Observational Study
Colorectal Cancer ScreeningColorectal Cancer (CRC)Microbiome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 74
Sex
Any
Study type
Observational
Participants needed
30,000 (estimated)
Sponsor
Gulbenkian Institute for Molecular Medicine · Other
Who this trial is looking for
This trial is looking for adults aged 40 to 74 living in the Lisbon area. Participants will provide stool samples to help identify biomarkers for early detection of colorectal cancer.
I can provide informed consent and follow study procedures
I live in the Lisbon Metropolitan Area
I am between 40 and 74 years old
You may not be able to join if
I am younger than 40 years old
I am 75 years old or older
I cannot provide informed consent
I refuse to provide stool samples
I have an active oncological disease
I have a personal history of colorectal cancer
I have had colon adenomas removed in the last 24 months
I have a first-degree family history of colorectal cancer
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
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 samp…
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
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