Exploring the Feasibility of Cerebrospinal Fluid (CSF) and Blood Plasma Liquid Biopsy in Patients With Metastatic Solid Tumours and Primary Central Nervous System (CNS) Tumours: A Pilot Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • One time CSF and blood sample

    Procedure/Surgery

    One-time CSF collective via lumbar puncture or Ommaya reservoir and collection of concurrent plasma of peripheral blood (liquid biopsy).

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: CSF and Blood collectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number 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

Secondary outcomes

Other outcomes

Sponsors and contacts

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