Clinical trial · Observational
CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Early Onset Colorectal Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Microbiome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention: observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colorectal Cancer (CRC)
- description
- Participants with a confirmed CRC diagnosis, stratified by age: 40-49, 50-59, 60-64, 65-69, and 70-74 years.
- interventionNames
- Other: No intervention: observational study
Primary outcomes (3)
- measure
- Microbiome biomarkers associated with CRC.
- timeFrame
- Baseline and Follow-up up to 3 years
- description
- 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.
- measure
- Microbiome biomarkers associated with EoCRC.
- timeFrame
- Baseline and Follow-up up to 3 years
- description
- Similar analysis as Outcome number 1, focused specifically on early-onset CRC cases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available