CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention: observational study: No intervention: observational study

Study summary

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.

Eligibility

Primary outcome measure(s)

• Microbiome biomarkers associated with CRC. — Baseline and Follow-up up to 3 years
  The faecal microbiome's composition and gene profiles will be analysed using shotgun metagenomic sequencing. Data will be integrated with lifestyle and dietary factors to identify biomarkers linked to CRC stages.
• Microbiome biomarkers associated with EoCRC. — Baseline and Follow-up up to 3 years
  Similar analysis as Outcome number 1, focused specifically on early-onset CRC cases.
• Correlation between microbiome biomarkers and overall survival and disease-free survival. — 3 years
  Biomarkers will be correlated with clinical follow-up data, including overall survival (survivors vs non-survivors) and disease-free progression (relapse vs no relapse).

Trial sites (2)

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