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NCT Number: NCT06568679

Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer

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.

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Key information

Conditions

Early-onset Colorectal Cancer

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location status: Recruiting

Location contact

Karen Bolhuis

CONTACT

[email protected]

+31205129111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention; observational

Other

No intervention; observational

Primary outcomes

  1. 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

    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

  1. Second tumor

    Time frame: Change from baseline throughout follow-up of 10 years

    Linkage to the Netherlands Cancer Registry (NCR) and nationwide National Pathology Database (PALGA) to asses second malignancies.

  2. Psychological distress

    Time frame: Change from baseline throughout follow-up of 10 years

    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

  3. Survival

    Time frame: Change from baseline throughout follow-up of 10 years

    Linkage will done with the Personal Records Database (BRP) to have information on survival status

  4. Germline variants will be analysed in the carcinogenesis of EOCRC

    Time frame: Change from baseline throughout follow-up of 10 years

    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.

  5. 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

    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.

  6. High risk profiles

    Time frame: Change from baseline throughout follow-up of 10 years

    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.

  7. Geno-phenotype associations

    Time frame: Change from baseline throughout follow-up of 10 years

    Geno-phenotype associations of patients will be analysed in-depth based on whole genome sequencing (WGS), histopathological features and survival outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruud Weijer, PhD

CONTACT

[email protected]

+31205129111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Striving for Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer (EOCRC); BIO-EOCRC Study

Acronym: BIO-EOCRC

Important dates

Study start
2025
Primary completion
2037
Study completion
2038
First posted
Aug 23, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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