Striving for earlier detection and optimization of treatment and prognosis for patients with early-onset colorectal cancer (EOCRC); BIO-EOCRC study

The incidence of early-onset (<50 years) colorectal cancer (EOCRC) is rapidly
increasing (average annual increase 2-4%). Importantly, EOCRC shows a distinct
tumor biology with more often advanced stages at presentation and this results
in worse survival. In addition, a cancer diagnosis and treatment(s) can lead to
long-term morbidity and disrupt physical, cognitive, and psychosocial
development, which can result in a reduced health-related quality of life
(HRQOL) in this young population. This has led the US National Cancer Institute
to rank this area of unmet need as research priority. Exposomes (including
diet, lifestyle and microbiome) in combination with novel genetic variants have
been suggested to play an etiological role in EOCRC carcinogenesis. However,
data are scattered and based on retrospective studies, with contradicting
results. Prospective multiomics studies are warranted for a better
understanding of biology and pathogenesis and to enable analysis of diagnostic
biomarkers to develop both preventive and early detection strategies.

To develop a prediction model for EOCRC patients that estimates the risk of
having low HRQoL one year after inclusion based on a comprehensive set of
predictors including patient characteristics, disease and treatment factors,
lifestyle variables and psychosocial factors.

Monocenter, prospective, observational cohort study.

On an individual level, patients who participate are asked to complete
questionnaires at baseline and on an annual basis for at least 10 years
concordant with the COMPRAYA (2.0) study. All sample collections (faeces,
serum) will take place at three to five time points during standard follow up
hospital visit: at baseline and during or after treatment at 3 months (only if
patient receives systemic treatment), 6 months and 12 months and at disease
recurrence after treatment with curative intent; tissue biopsies and blood
sample for whole genome sequencing (WGS) will only take place at baseline. A
tumor biopsy is optional in case of recurrent disease. The collection of blood
and faeces is minimally invasive and the risks are negligible. Primary tumor
and colon biopsies are performed during standard of care endoscopies and the
general risks of colonoscopy and tissue biopsies apply. WGS will be performed
on biopsy from the primary tumor or metastatic lesion and on blood sample and
falls under the routine diagnostics for molecular analysis in metastatic
colorectal cancer. All safety measures and procedures will be performed
according to local guidelines. Patients will not experience direct benefit from
participation in the BIO-EOCRC study. However, by participating, patients will
contribute to a better insight in the biology and pathogenesis of early-onset
(<=50 years) colorectal cancer (EOCRC).