NCT06734156Recruiting
CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 11 Dec 2024
- Start date
- 2 Mar 2026
- Primary completion date
- 2 Dec 2026
- Lead sponsor
- Gulbenkian Institute for Molecular Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT06734156
What you commit to
- Study type: Observational
- Planned participants: 400
- From 2 Mar 2026 to the primary completion date, 2 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current treatment for CRC
- Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, recurrent infection by Clostridioides difficile
Other illness
- First-degree family history of CRC
Age
- Age \< 40 years or ≥ 75 years
Other
- Unable to provide informed consent
- Refusal to provide stool samples
- Pregnancy
Who the study is looking for
- Be willing and able to provide written informed consent
- Resident in Portugal
- Age from 40 to 74 years
- Have a recent diagnosis of CRC without initiating any treatment.
Age in the registry: 40 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gulbenkian Institute for Molecular Medicine Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Champalimaud Foundation Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.