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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Early-onset Colorectal Cancer
• Intervention / Treatment: Other: No intervention; observational

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Ruud Weijer, PhD; Phone Number: +31205129111; Email: r.weijer@nki.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066CX
      • Recruiting
      • Netherlands Cancer Institute
      • Contact: Karen Bolhuis; Phone Number: +31205129111; Email: k.bolhuis@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Dutch Digestive Diseases Foundation
• Investigators: Principal Investigator: Karen Bolhuis, MD, PhD, the Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2038

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: N24ECR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No