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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-49
SponsorThe Netherlands Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Mentally incompetent patients based on the opinion of treating physician

Inability to understand the Dutch language

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention; observational

    Other intervention

    No intervention; observational

Treatment groups

No treatment groups listed

Trial outcomes

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.

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

Secondary outcomes

1

Second tumor

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

Time frame
Change from baseline throughout follow-up of 10 years
2

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

Time frame
Change from baseline throughout follow-up of 10 years
3

Survival

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

Time frame
Change from baseline throughout follow-up of 10 years
4

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.

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

Other outcomes

Sponsors and contacts

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