Actively Recruiting
CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
Led by Gulbenkian Institute for Molecular Medicine · Updated on 2026-05-12
400
Participants Needed
2
Research Sites
195 weeks
Total Duration
On this page
Sponsors
G
Gulbenkian Institute for Molecular Medicine
Lead Sponsor
F
Fundacao Champalimaud
Collaborating Sponsor
AI-Summary
What this Trial Is About
Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths globally, with increasing incidence rates. While predominantly affecting older adults, CRC cases among individuals under 50 (early-onset CRC, or EoCRC) are rising. This age group rarely undergoes routine screening, resulting in delayed diagnoses and more advanced disease at presentation. In the USA, EoCRC accounts for 10% of CRC cases and is the leading cause of cancer-related deaths in men under 50. Despite the increase in EoCRC incidence, the causes remain unclear. Only 25% of cases have a CRC family history, suggesting environmental factors. Diets low in fibre and rich in fat and red meat, obesity, alcohol consumption, sedentary lifestyle, stress, and chronic inflammation of the GI tract are estimated to account for 70-90% of CRC risk. According to the World Cancer Research Fund, 47% of all CRC cases could be prevented through lifestyle changes, particularly in diet and physical activity. These lifestyle factors are also strongly linked to changes in the gut microbiome, which differs markedly between CRC patients and healthy individuals. The microbiome may influence tumour development by producing metabolites that regulate immune responses or create anti-tumour environments. Thus, the gut microbiome is a promising target for early CRC detection and prevention. This study aims to develop a non-invasive, microbiome-based diagnostic tool for CRC, identifying biomarkers to improve early detection, personalise treatment, and reduce healthcare costs.
CONDITIONS
Official Title
CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be willing and able to provide written informed consent
- Resident in Portugal
- Age from 40 to 74 years
- Have a recent diagnosis of colorectal cancer without starting any treatment
You will not qualify if you...
- Age younger than 40 years or 75 years and older
- Unable to provide informed consent
- Refusal to provide stool samples
- Previous or current treatment for colorectal cancer
- First-degree family history of colorectal cancer
- Previous diagnosis of inflammatory bowel disease, irritable bowel syndrome, or recurrent Clostridioides difficile infection
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Champalimaud Foundation
Lisbon, Lisbon District, Portugal, 1400-038
Actively Recruiting
2
Gulbenkian Institute for Molecular Medicine
Lisbon, Lisbon District, Portugal, 1649-028
Actively Recruiting
Research Team
A
Ana S Almeida, PhD
CONTACT
M
Madalena Reis
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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