About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Mentally incompetent patients based on the opinion of treating physician
Inability to understand the Dutch language
Trial population
Patients with histologically proven CRC aged 18-49 years (EOCRC) are eligible for participation in this study regardless of stage and treatment of the disease.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention; observational
Other interventionNo intervention; observational
Treatment groups
Trial outcomes
Primary outcomes
Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC
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.
Secondary outcomes
Second tumor
Linkage to the Netherlands Cancer Registry (NCR) and nationwide National Pathology Database (PALGA) to asses second malignancies.
Psychological distress
Psychological distress will be assessed at each time point with the Hospital Anxiety and Depression Scale (HADS), with seven items each for assessing symptoms of anxiety and depression
Survival
Linkage will done with the Personal Records Database (BRP) to have information on survival status
Germline variants will be analysed in the carcinogenesis of EOCRC
The frequencies of germline variants that are known risk factors to cancer development will be determined. Generally, hereditary colorectal cancers will be analyzed both together with and separately from sporadic colorectal cancers. The contribution of germline variants to carcinogenesis via mutational signatures will be determined, where possible, using linear mixed models.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.