About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients in Cohort A will have previously untreated or progressing leptomeningeal metastatic disease (LMD) with or without parenchymal brain metastases (BrM).
Patients in Cohort B will have previously untreated or BrM but no evidence of LMD.
Patients in Cohort C will have progressing extra-cranial metastatic disease with no LMD or BrM.
Patients in Cohort D will have primary CNS tumours (such as, but not limited to, meningioma, glioblastoma, astrocytoma, ependymoma, and other rare histologies).
Disqualifiers
Inability to understand or unwillingness to provide written informed consent (language barriers are not exclusionary; the use of a translator is permitted).
Patients with contraindications to lumbar puncture (e.g., infection at the LP site, uncontrolled bleeding diathesis > 1.5], severe thrombocytopenia [platelet count <40,000/µL], use of anticoagulant or antiplatelet medications cannot be safely interrupted, significant mass effect with risk of herniation, or presence of vertebral hardware)
Trial design
Single group
Treatments tested in this trial
One time CSF and blood sample
Procedure/SurgeryOne-time CSF collective via lumbar puncture or Ommaya reservoir and collection of concurrent plasma of peripheral blood (liquid biopsy).
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with positive cerebrospinal fluid (CSF) biomarkers in each cohort.
CSF biomarkers include cytology, ctDNA, and circulating tumor cells
Sponsors and contacts
Click on the lead sponsor to view all of their trials.