CSF and Blood Plasma Liquid Biopsy in Patients With Metastatic Solid Tumours and CNS Metastases or no CNS Metastases

NCT07476781 | Recruiting

• 1 other identifier: REB 6840
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Solid Tumor Malignancies; Brain Metastasases; Leptomeningeal Disease (LMD)

Outcome Measures

Primary Outcomes (1)

• To estimate the proportion of patients with solid tumours and CNS metastases (either meeting criteria for Cohort A or B), or no CNS metastases (Cohort C) who have positive CSF cytology, positive ctDNA, and/or positive CTCs

  From enrollment to the CSF and plasma collection, within 2-4 weeks

Study Arms (1)

CSF and Blood collection

EXPERIMENTAL

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

Procedure: One time CSF and blood sample

Interventions

One time CSF and blood sample PROCEDURE

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

CSF and Blood collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with a metastatic solid tumour in one of the following scenarios:
• Patients in Cohort A will have leptomeningeal metastatic disease (LMD) with or without parenchymal brain metastases.
• Patients in Cohort B will have parenchymal brain metastases but no evidence of LMD.
• Patients in Cohort C will have metastatic solid tumours no CNS metastases (i.e. no LMD nor brain metastases).
• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M8Z 3X1, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 39704899 BACKGROUND

MeSH Terms

Conditions

Meningeal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Katarzyna Jerzak, Dr

CONTACT

416-480-5000; katarzyna.jerzak@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 17, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-11

Locations

CA (1)