Striving for Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer (EOCRC); BIO-EOCRC Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC
研究概览
简要总结
The study aims to collect high quality clinical data on lifestyle and patient biomaterials prior to start or during / after treatment of early-onset colorectal cancer (EOCRC) and to inform on treatment and survival outcomes of EOCRC patients.
详细描述
The current study will be complementary to COMPRAYA, a prospective cohort study focused on risk factors of impaired medical and psychosocial outcomes of adolescents and young adults with cancer (AYA) and to GENAYA, focused on genetic testing of AYA. The collected data and materials will be essential for an in-depth analysis of the epidemiology, exposomes and pathophysiology of EOCRC and compare this with average-onset CRC (AOCRC) and healthy controls. These data will facilitate multiomics studies and the identification of high-risk profiles and blood- and/or stool-based biomarkers, which in turn will enable the development of prevention and early detection strategies to ultimately improve prognosis and the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among EOCRC patients wil be examined.
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
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with locoregional or metastatic colorectal cancer (CRC)
- •Histologically proven CRC
- •Age 18 - 49 years at time of first CRC diagnosis
- •Able to understand the informed consent form
- •Provide written informed consent.
排除标准
- •Mentally incompetent patients based on the opinion of treating physician
- •Inability to understand the Dutch language
结局指标
主要结局
Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC
时间窗: Change from baseline throughout follow-up of 10 years
Associations between exposome (lifestyle factors and microbiome composition), genomics and transcriptomics and EOCRC will be determined by multivariate analysis. Multivariate tests will be applied to account for the complexity of the data and the multitude of variables involved, this will include multiple regression analysis, logistic regression analysis, and analysis of variance (ANOVA). These tests will allow us to identify and quantify the correlation between the factors and better understand the underlying mechanisms of EOCRC.
次要结局
- To compare stage-specific treatment and survival outcomes of patients with EOCRC with those of AOCRC (≥ 50 years)(Change from baseline throughout follow-up of 10 years)
- High risk profiles(Change from baseline throughout follow-up of 10 years)
- Survival(Change from baseline throughout follow-up of 10 years)
- Second tumor(Change from baseline throughout follow-up of 10 years)
- Germline variants will be analysed in the carcinogenesis of EOCRC(Change from baseline throughout follow-up of 10 years)
- Psychological distress(Change from baseline throughout follow-up of 10 years)
- Geno-phenotype associations(Change from baseline throughout follow-up of 10 years)