CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
Recruiting · NCT06734156 · Observational (researchers observe without assigning treatment) · Lead sponsor: Gulbenkian Institute for Molecular Medicine
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Age \< 40 years or ≥ 75 years
- Unable to provide informed consent
- Refusal to provide stool samples
- Previous or current treatment for CRC
- First-degree family history of CRC
- Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, recurrent infection by Clostridioides difficile
- Pregnancy
Where it is running
2 locations listed.
- Champalimaud Foundation - Lisbon, Lisbon District, Portugal
- Gulbenkian Institute for Molecular Medicine - Lisbon, Lisbon District, Portugal