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Trial Title:
Earlier Detection and Optimization of Treatment and Prognosis for Patients with Early-onset Colorectal Cancer
NCT ID:
NCT06568679
Condition:
Early-onset Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention; observational
Description:
No intervention; observational
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
49 Years
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
December 1, 2038
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06568679
