This is a prospective, single-centre feasibility study of CSF ctDNA conducted at the Sunnybrook Odette Cancer Centre (SOCC), Toronto, Canada, including multiple solid tumor, stratified into cohorts according to CNS disease involvement, including leptomeningeal disease (Cohort A), parenchymal brain metastases (Cohort B), and no evidence of CNS metastases (Cohort C).
Current plasma-based liquid biopsy approaches have limited ability to reflect CNS disease in patients with solid tumor. Since CSF is in direct contact with CNS disease, CSF analysis may provide more relevant biological information; however, its role as a liquid biopsy source has not been well characterized across different patterns of CNS involvement. The goal of this pilot study is to evaluate the feasibility and utility of CSF-based liquid biopsy in patients with solid tumor with and without CNS metastases, in addition to primary CNS tumors. Four predefined cohorts will be studied: patients with leptomeningeal disease (Cohort A), patients with active parenchymal brain metastases (BrM) (Cohort B), patients without evidence of BrM (Cohort C), and patients with primary CNS tumours (Cohort D). Participants will undergo a one-time CSF collection via lumbar puncture or Ommaya reservoir, with concurrent collection of peripheral blood for plasma-based liquid biopsy. Aim 1: To determine the proportion of patients with positive CSF biomarkers, including cytology and circulating tumor DNA (ctDNA) in each cohort. Aim 2: To compare ctDNA results obtained from CSF with those obtained from plasma in each cohort. Aim 3: To evaluate the feasibility of performing proteomic analysis using CSF samples in patients with at least one positive CSF biomarker (cytology and/or ctDNA). If successful, the investigators will explore proteomic analyses in CSF biomarker negative patients to potentially identify more sensitive signatures for CNS metastasis detection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
One-time CSF collective via lumbar puncture or Ommaya reservoir and collection of concurrent plasma of peripheral blood (liquid biopsy).
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGNumber of patients with positive cerebrospinal fluid (CSF) biomarkers in each cohort.
CSF biomarkers include cytology, ctDNA, and circulating tumor cells
Time frame: From enrollment to the CSF and plasma collection, within 2-4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.