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

NCT06568679 | Recruiting

• 1 other identifier: N24ECR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early-onset Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Second tumor

  Change from baseline throughout follow-up of 10 years

• Psychological distress

  Change from baseline throughout follow-up of 10 years

• Survival

  Change from baseline throughout follow-up of 10 years

• Germline variants will be analysed in the carcinogenesis of EOCRC

  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)

  Change from baseline throughout follow-up of 10 years

Interventions

No intervention; observational OTHER

No intervention; observational

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Mentally incompetent patients based on the opinion of treating physician
• Inability to understand the Dutch language

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopsies, blood samples, stool samples

Study Officials

• Karen Bolhuis, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruud Weijer, PhD

CONTACT

+31205129111; r.weijer@nki.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 23, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2038
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)