Cerebral spinal fluid analyses and therapeutic implications for leptomeningeal metastatic disease.
Jie Wei Zhu, Megan Shum, Maleeha A Qazi...
https://pubmed.ncbi.nlm.nih.gov/39704899Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07476781
Exploring the Feasibility of Cerebrospinal Fluid Liquid Biopsy in Patients With Metastatic Solid Tumours With or Without Central Nervous System Metastases
Led by Sunnybrook Health Sciences Centre · Updated on 2026-03-17
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and usefulness of cerebrospinal fluid (CSF)-based liquid biopsy in patients with metastatic solid tumors, including those with and without involvement of the central nervous system (CNS). This pilot study includes three groups: patients with leptomeningeal disease (Cohort A), those with active brain metastases (Cohort B), and those without CNS metastases (Cohort C). The study aims to better understand how CSF analysis can provide biological information that plasma-based liquid biopsy may miss in CNS disease. All participants will undergo a one-time collection of CSF via lumbar puncture or through an Ommaya reservoir, along with a blood draw for plasma-based liquid biopsy. The study will assess the presence of biomarkers such as cytology, circulating tumor DNA (ctDNA), and circulating tumor cells (CTCs) in the CSF and compare these results to those found in plasma. Proteomic analysis of CSF samples will also be explored in patients with positive CSF biomarkers and may be extended to those without detectable biomarkers to identify sensitive indicators of CNS metastasis. Participants will have their CSF and blood samples collected once within 2 to 4 weeks of enrollment. Researchers will measure the proportion of patients with positive CSF cytology, ctDNA, and/or CTCs across the three cohorts. The study team will monitor biomarker detection and feasibility of proteomic tests, providing insights into CNS involvement in metastatic solid tumors. The total participation involves this single visit and sample collection, with study completion expected by December 2026.
CONDITIONS
Brief Title
CSF and Blood Plasma Liquid Biopsy in Patients With Metastatic Solid Tumours and CNS Metastases or no CNS Metastases
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with a metastatic solid tumour in one of these groups: leptomeningeal disease (with or without brain metastases), parenchymal brain metastases without leptomeningeal disease, or no CNS metastases
- Suitable for lumbar puncture or have an accessible Ommaya reservoir for CSF collection
- Eligible at any treatment stage, including those already treated for leptomeningeal disease
- For patients with active brain metastases, newly diagnosed untreated lesions or progressing previously treated lesions
- Patients previously enrolled with negative CSF biomarkers may be re-enroll upon CNS disease progression
You will not qualify if you...
- Unable or unwilling to provide written informed consent (language barriers allowed with translator)
- Contraindications to lumbar puncture such as infection at puncture site, uncontrolled bleeding disorders, severe low platelet count, inability to safely stop blood-thinning medications, significant brain mass effect risking herniation, or presence of vertebral hardware
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
CSF and Blood Collection
Duration - One day
Participants undergo a one-time cerebrospinal fluid collection via lumbar puncture or Ommaya reservoir, along with a concurrent peripheral blood draw for plasma-based liquid biopsy.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M8Z 3X1
Actively Recruiting
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Research Team
K
Katarzyna Jerzak, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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