Solid Tumor MalignanciesECLIPSENCT07476781
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
A study testing One time CSF and blood sample in people with Solid Tumor Malignancies and Brain Metastasases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies, Brain Metastasases, Leptomeningeal Disease (LMD)
- What is being tested?
- One time CSF and blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a solid tumour in one of the following scenarios:
- 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).
- Patient is suitable for lumbar puncture and/or has an Ommaya reservoir that is accessible for CSF collection.
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- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M8Z 3X1
Katarzyna Jerzak, Dr, 416-480-5000, katarzyna.jerzak@sunnybrook.ca
About this study
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.
- Conditions
- Solid Tumor Malignancies, Brain Metastasases, Leptomeningeal Disease (LMD), Central Nervous System
- Being tested
- One time CSF and blood sample
- Medical subject headings
- Meningeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One time CSF and blood sampleProcedure or surgery
One-time CSF collective via lumbar puncture or Ommaya reservoir and collection of concurrent plasma of peripheral blood (liquid biopsy).
| Study group | Role | What they receive |
|---|---|---|
| CSF and Blood collection | Experimental | All the patients will perform the same intervention (One-time CSF and blood sample) Receives: Procedure: One time CSF and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive cerebrospinal fluid (CSF) biomarkers in each cohort.
CSF biomarkers include cytology, ctDNA, and circulating tumor cells
Measured: From enrollment to the CSF and plasma collection, within 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start12 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-time CSF collective via lumbar puncture or Ommaya reservoir and collection of concurrent plasma of peripheral blood (liquid biopsy).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476781
- Sponsor's protocol ID
- REB 6840
- Acronym
- ECLIPSE
- Status last verified
- Nov 2025
- First submitted
- 3 Mar 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07476781
- Acronym / sponsor ID
- ECLIPSE / REB 6840
- Conditions
- Solid Tumor Malignancies, Brain Metastasases, Leptomeningeal Disease (LMD), Central Nervous System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-time CSF collective via lumbar puncture or Ommaya reservoir and collection of concurrent plasma of peripheral blood (liquid biopsy).
| Arm | Type | Receives |
|---|---|---|
| CSF and Blood collection | Experimental | Procedure: One time CSF and blood sampleAll the patients will perform the same intervention (One-time CSF and blood sample) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with a solid tumour in one of the following scenarios:
- 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).
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One time CSF and blood sampleOne-time CSF collective via lumbar puncture or Ommaya reservoir and collection of concurrent plasma of peripheral blood (liquid biopsy). | Procedure or surgery | CSF and Blood collection |
Primary outcome
Number of patients with positive cerebrospinal fluid (CSF) biomarkers in each cohort.
Time frame: From enrollment to the CSF and plasma collection, within 2-4 weeks
CSF biomarkers include cytology, ctDNA, and circulating tumor cells
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 39704899Zhu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One time CSF and blood sample in people with Solid Tumor Malignancies and Brain Metastasases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Jerzak, Dr (416-480-5000, katarzyna.jerzak@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with positive cerebrospinal fluid (CSF) biomarkers in each cohort. (time frame: From enrollment to the CSF and plasma collection, within 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07476781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.