Spinal fluid and blood liquid biopsy for people with metastatic solid tumors with or without brain involvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-centre feasibility project at Sunnybrook collects a one-time CSF sample (via lumbar puncture or Ommaya reservoir) and concurrent blood for plasma-based liquid biopsy from three predefined cohorts: leptomeningeal disease, parenchymal brain metastases without LMD, and no CNS metastases. Investigators will measure CSF cytology, circulating tumor DNA (ctDNA), and circulating tumor cells (CTCs), compare those results to plasma, and determine the proportion of patients with detectable CSF biomarkers in each cohort. The study will also explore CSF proteomic analysis in patients with positive CSF biomarkers and possibly extend proteomics to biomarker-negative samples if feasible. The goal is to define feasibility and the added value of CSF versus plasma for detecting CNS tumor-derived signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with a solid tumour in one of the following scenarios:

  1. Patients in Cohort A will have previously untreated or progressing leptomeningeal metastatic disease (LMD) with or without parenchymal brain metastases (BrM).
  2. Patients in Cohort B will have previously untreated or BrM but no evidence of LMD.
  3. Patients in Cohort C will have progressing extra-cranial metastatic disease with no LMD or BrM.
  4. Patients in Cohort D will have primary CNS tumours (such as, but not limited to, meningioma, glioblastoma, astrocytoma, ependymoma, and other rare histologies).
* Patient is suitable for lumbar puncture and/or has an Ommaya reservoir that is accessible for CSF collection.
* Patient is eligible at any time point in their treatment course, including whether or not they have already started treatment for LMD. Considering the poor prognosis associated with LMD, rapid clinical deterioration, and the fact that available local and systemic therapies have not been shown to completely eradicate LMD, there is a high likelihood of detecting CSF biomarkers regardless of the timing of assessment. This flexible enrollment strategy is particularly important to support feasibility and recruitment in this less common and clinically challenging population. However, efforts will be made to collect CSF samples prior to treatment initiation and/or at the time of disease progression whenever possible.
* Patients with active brain metastases, defined as newly diagnosed and previously untreated lesions, or lesions that were previously treated and are now progressing.
* Patients who were previously enrolled in the study and had negative CSF biomarkers may be re-enrolled at a later time point (e.g., upon progression of CNS disease).

Exclusion Criteria:

* 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)

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Katarzyna Jerzak, Dr
• Email: katarzyna.jerzak@sunnybrook.ca
• Phone: 416-480-5000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.