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RecruitingNCT07476781ECLIPSEUpdated Jul 31, 2026

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

An interventional study of One time CSF and blood sample in Solid Tumor Malignancies, Brain Metastasases and Leptomeningeal Disease (LMD), sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Solid Tumor Malignancies
  • Brain Metastasases
  • Leptomeningeal Disease (LMD)
  • Central Nervous System

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03

In context

Meningeal Neoplasms

40 studies on the registry are indexed under Meningeal Neoplasms; 17 are open to participants now.

This study's planned enrollment of 60 is above the median of 33 across 33 interventional studies indexed under Meningeal Neoplasms.

Browse Meningeal Neoplasms studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Browse Sunnybrook Health Sciences Centre studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

    1. Patients in Cohort A will have previously untreated or progressing disease (LMD) with or without parenchymal (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

Exclusion Criteria:

  • Inability to understand or unwillingness to provide written (language barriers are not exclusionary; the use of a translator is permitted).
  • Patients with to lumbar puncture (e.g., infection at the LP site, uncontrolled bleeding diathesis > 1.5], severe thrombocytopenia [ 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)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    CSF and Blood collection

    All the patients will perform the same intervention (One-time CSF and blood sample)

    Procedure: One time CSF and blood sample

Interventions

  • ProcedureOne time CSF and blood sample

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Zhu JW, Shum M, Qazi MA, Sahgal A, Das S, Dankner M, Menjak I, Lim-Fat MJ, Jerzak KJ. Cerebral spinal fluid analyses and therapeutic implications for leptomeningeal metastatic disease. J Neurooncol. 2025 Mar;172(1):31-40. doi: 10.1007/s11060-024-04902-0. Epub 2024 Dec 20. PubMed 39704899 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2026
First posted
Mar 17, 2026
StartActual
Dec 12, 2025
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07476781
Lead sponsor
Sunnybrook Health Sciences Centre
Responsible party
Sponsor
First posted
Mar 17, 2026
Start date
Dec 12, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 31, 2026

Study contacts

Katarzyna Jerzak, Dr
Contact
katarzyna.jerzak@sunnybrook.ca
416-480-5000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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