Clinical trial NCT06568679: Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer
Official title: Striving for Earlier Detection and Optimization of Treatment and Prognosis for Patients With Early-onset Colorectal Cancer (EOCRC); BIO-EOCRC Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early-onset Colorectal Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exploratory data analysis through a multiomics approach describing tumor biology and pathogenesis of patients with EOCRC
timeFrame: Change from baseline throughout follow-up of 10 years
Secondary outcomes:
measure: Second tumor
timeFrame: Change from baseline throughout follow-up of 10 years
measure: Psychological distress
timeFrame: Change from baseline throughout follow-up of 10 years
measure: Survival
timeFrame: Change from baseline throughout follow-up of 10 years
measure: Germline variants will be analysed in the carcinogenesis of EOCRC
timeFrame: Change from baseline throughout follow-up of 10 years
measure: To compare stage-specific treatment and survival outcomes of patients with EOCRC with those of AOCRC (≥ 50 years)
timeFrame: Change from baseline throughout follow-up of 10 years
measure: High risk profiles
timeFrame: Change from baseline throughout follow-up of 10 years
measure: Geno-phenotype associations
timeFrame: Change from baseline throughout follow-up of 10 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord-Holland
Study officials:
affiliation: The Netherlands Cancer Institute
name: Karen Bolhuis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: