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
156 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
This research aims to develop a non-invasive diagnostic tool based on the gut microbiome to improve early detection of colorectal cancer (CRC), focusing particularly on early-onset CRC (EoCRC) in people under 50. CRC is a leading cause of cancer deaths worldwide, with rising cases among younger adults who often face delayed diagnosis. The study explores how lifestyle factors and gut microbiome changes may contribute to CRC risk and progression. Participants diagnosed with CRC but not yet treated will be included, aged 40 to 74 years. Faecal and blood samples will be collected at diagnosis, after treatment, and during a three-year follow-up. The study will analyze microbiome profiles, clinical data, and lifestyle factors such as diet, physical activity, stress, and body mass index. A control group of healthy individuals undergoing routine screening colonoscopies will also be recruited. During the study, researchers will monitor survival rates, disease progression, and therapeutic responses while assessing microbiome changes and lifestyle impacts. Data will be gathered through questionnaires and interviews about diet and habits. Microbiome analysis will use advanced sequencing methods to identify biomarkers linked to CRC stages, prognosis, and treatment outcomes over three years, aiming to support personalized prevention and care strategies.
CONDITIONS
Brief 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 under 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 (ulcerative colitis, Crohn's disease, or indeterminate colitis), inflammatory bowel syndrome, or recurrent Clostridioides difficile infection
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline (at diagnosis and study entry)
Participants provide baseline faecal and blood samples at diagnosis and study entry, and complete lifestyle and dietary questionnaires.
1 baseline visit (in-person or remote)
Duration - Up to 3 years after diagnosis
Participants provide faecal and blood samples after completing each therapeutic regimen and at three years post-diagnosis, with ongoing monitoring of survival rates and disease progression.
3 visits at key time points: post-treatment and 3-year follow-up
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
M
Madalena Reis
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here