Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer
NCT Number: NCT06568679
Acronym: BIO-EOCRC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Early-onset Colorectal Cancer
Interventions: OTHER: No intervention; observational
Sponsor: The Netherlands Cancer Institute
Collaborators: Dutch Digestive Diseases Foundation
Sex: ALL
Age: ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2038-10-01

Summary:
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.

Primary Outcome Measures: 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., Change from baseline throughout follow-up of 10 years
Secondary Outcome Measures: Second tumor, Linkage to the Netherlands Cancer Registry (NCR) and nationwide National Pathology Database (PALGA) to asses second malignancies., Change from baseline throughout follow-up of 10 years|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, Change from baseline throughout follow-up of 10 years|Survival, Linkage will done with the Personal Records Database (BRP) to have information on survival status, Change from baseline throughout follow-up of 10 years|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., Change from baseline throughout follow-up of 10 years|To compare stage-specific treatment and survival outcomes of patients with EOCRC with those of AOCRC (≥ 50 years), Treatment and survival outcomes (progression free survival and/or recurrence free survival and overall survival) will be estimated with Kaplan-Meier curves and medians with 95% confidence intervals (CIs) will be presented and will be compared to survival outcomes of AOCRC (≥ 50 years) of a matched control group from the NCR., Change from baseline throughout follow-up of 10 years|High risk profiles, By a multiomics approach associations between exposomes (lifestyle, microbiome), (epi-)genomics and transcriptomics in EOCRC development and tumor phenotype will be analysed to assign high risk profiles to provide rationale for the selection of target populations that should be offered CRC screening at an earlier age., Change from baseline throughout follow-up of 10 years|Geno-phenotype associations, Geno-phenotype associations of patients will be analysed in-depth based on whole genome sequencing (WGS), histopathological features and survival outcomes., Change from baseline throughout follow-up of 10 years