Improving Colorectal Cancer Early Screening in Portugal: Identification of Gut Microbiome Biomarkers in Stool (GUTBIOME-PT)
NCT ID: NCT06741293
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30000 participants
OBSERVATIONAL
2023-11-28
2029-11-28
Brief Summary
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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.
Detailed Description
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Primary Objective:
To identify gut microbiome biomarkers in faecal DNA associated with CRC and/or high-risk adenomas.
Secondary Objectives:
i) Establish the correlation between FIT results, faecal microbiome testing and colonoscopy results.
ii) Estimate the incidence of CRC in the Lisbon Metropolitan Area among individuals aged 40-74 years, stratified by sex and age group.
iii) Analyse associations between clinical data (e.g., clinical history, lifestyle, and dietary habits), faecal microbiome profiles, FIT results, and colonoscopy outcomes, comparing individuals with CRC and/or high-risk adenomas against healthy individuals, for the total sample and by sex and age group; iv) Identify risk factors (e.g., clinical history, lifestyle, dietary habits) associated with CRC development, stratified by sex and age group.
Study Design:
This is an observational, prospective, longitudinal study involving individuals aged 40-74 years residing in the Lisbon Metropolitan Area who voluntarily enrol in the study.
Participants meeting all inclusion criteria and no exclusion criteria (as detailed in the relevant section) will be included. Based on sample size calculations using the Neyman allocation formula and taking as a reference the distribution of the population living in the Lisbon Metropolitan Area (stratified by sex and age groups: 40-49, 50-59, 60-64, 65-69 and 70-74 years), along with assumptions of the overall FIT test prevalence and sensitivity, a total of 30.000 participants will be enrolled.
At baseline, participants will provide a faecal sample within 2 to 10 days of enrolment. Demographic, clinical, and lifestyle data-including age, family history of CRC, personal medical history, smoking habits, physical activity levels, stress, and body mass index (BMI)-will be collected via self-administered questionnaires. Dietary habits and adherence to the Mediterranean diet will be assessed through telephone interviews.
Participants will be followed for six years, with faecal samples collected every 2 years. Clinical and lifestyle data will also be updated every two years throughout the study period.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control group
Healthy participants with a negative colonoscopy result
No intervention: observational study
No intervention: observational study
Colorectal cancer
Participants with colorectal cancer diagnosis confirmed by colonoscopy
No intervention: observational study
No intervention: observational study
Low-risk polyps
Participants with positive colonoscopy and detection of low-risk adenomas
No intervention: observational study
No intervention: observational study
High-risk polyps
Participants with positive colonoscopy and detection of high-risk adenomas
No intervention: observational study
No intervention: observational study
Interventions
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No intervention: observational study
No intervention: observational study
Eligibility Criteria
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Inclusion Criteria
* Reside in the Lisbon Metropolitan Area,, Portugal
* Age from 40 to 74 years
Exclusion Criteria
* 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
40 Years
74 Years
ALL
Yes
Sponsors
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Hospital CUF Descobertas, Lisbon, Portugal
UNKNOWN
CUF Tejo Hospital
UNKNOWN
Hospital da Luz Lisboa, Portugal
UNKNOWN
Gulbenkian Institute for Molecular Medicine
OTHER
Responsible Party
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Locations
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Gulbenkian Institute for Molecular Medicine
Lisbon, Lisbon District, Portugal
Countries
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Central Contacts
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Facility Contacts
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Madalena Reis
Role: primary
Ana S Almeida, PhD
Role: backup
Related Links
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Public study website
Other Identifiers
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101060102
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CAML Ref Nº: 111/23
Identifier Type: -
Identifier Source: org_study_id