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

NCT ID: NCT06568679

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-27

Study Completion Date

2038-12-01

Brief Summary

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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

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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.

Conditions

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Early-onset Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention; observational

No intervention; observational

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Bolhuis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Ruud Weijer, PhD

Role: CONTACT

+31205129111

Facility Contacts

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Karen Bolhuis

Role: primary

+31205129111

Other Identifiers

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N24ECR

Identifier Type: -

Identifier Source: org_study_id

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