Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention; observational.
- Who it may be relevant to
- Registry conditions: Early-onset Colorectal Cancer. Basic parameters: 18 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Striving for Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer (EOCRC); BIO-EOCRC Study
Overview
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.
Detailed description
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.
Interventions
- Other No intervention; observational
No intervention; observational
Primary outcome measures
- Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC [Time frame: Change from baseline throughout follow-up of 10 years]
Secondary outcome measures (7)
- Second tumor [Time frame: Change from baseline throughout follow-up of 10 years]
- Psychological distress [Time frame: Change from baseline throughout follow-up of 10 years]
- Survival [Time frame: Change from baseline throughout follow-up of 10 years]
- Germline variants will be analysed in the carcinogenesis of EOCRC [Time frame: 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) [Time frame: Change from baseline throughout follow-up of 10 years]
- High risk profiles [Time frame: Change from baseline throughout follow-up of 10 years]
- Geno-phenotype associations [Time frame: Change from baseline throughout follow-up of 10 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Mentally incompetent patients based on the opinion of treating physician
- Inability to understand the Dutch language
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Netherlands Cancer Institute — Amsterdam
Identifiers
NCT: NCT06568679 · N24ECR