CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Microbiome biomarkers associated with CRC.
研究概览
简要总结
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.
详细描述
This study focuses on identifying faecal microbiome biomarkers for CRC across different stages, prognoses, and therapeutic responses, with a particular emphasis on EoCRC. Recruitment will include individuals recently diagnosed with CRC who have not undergone treatment.
Faecal samples will be collected at three key time points:
Baseline - At diagnosis and study entry. Post-Treatment - After completing each therapeutic regimen, such as neoadjuvant chemotherapy, surgery and/or adjuvant chemotherapy Follow-Up - Three years after diagnosis. The study will also monitor survival rates and disease progression over three years.
Primary Objective:
To identify and characterise changes in the gut microbiome at different CRC stages.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Microbiome biomarkers associated with CRC.
时间窗: 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.
时间窗: 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.
时间窗: 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).
次要结局
- Effect of diet on CRC risk and gut microbiota composition(Baseline)
- Effect of the Mediterranean Diet (MD) on CRC risk and gut microbiota composition(Baseline)
- Effect of physical activity on CRC risk and gut microbiota composition(Baseline)
- Effect of sleeping habits on CRC risk and gut microbiota composition(Baseline)
- Effect of stress levels on CRC risk and gut microbiota composition(Baseline)
- Identify and quantity inflammation markers(Baseline and Follow-up up to 3 years)
- Differential gene expression in tumour samples(Baseline)