Recruiting

CSF Analysis

Sponsor:

British Columbia Cancer Agency

Code:

NCT05257967

Conditions

EGFR Activating Mutation

Leptomeningeal Metastasis

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lumbar puncture and Phlebotomy

Study Details

Brief summary:

Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. With improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of EGFR mutant NSCLC.

Systemic therapy may be more effective if it can target the correct molecular aberration. The molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) through the use of ddPCR and BC Cancer NGS panel molecular testing.

Conditions

EGFR Activating Mutation

Leptomeningeal Metastasis

Non Small Cell Lung Cancer

Study ID

NCT05257967

Start date

Jul 18, 2022

Status verified date

Feb, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject age is greater than or equal to 18 years at the time of signature of informed consent.
  • Histologically or cytologically confirmed metastatic EGFR mutant NSCLC.
  • Leptomeningeal disease based on brain MRI or CSF cytology.
  • ECOG 0-3.
  • Life expectancy of at least 8 weeks.
  • Adequate hematologic and end organ function for testing.
  • Ability to give informed consent for the study procedures defined in this protocol.

Exclusion Criteria:

  • Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.
  • Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
  • MRI spine demonstrating spinal leptomeningeal disease preventing a safe lumbar puncture.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Experimental arm

ddPCR and BC Cancer NGS panel completed on cerebral spinal fluid and blood circulating tumor DNA

Interventions

Lumbar puncture and Phlebotomy

Sampling of cerebral spinal fluid and plasma.

Primary outcome measure

  • Concordance of molecular profiling of CSF and plasma in EGFR mutation positive NSCLC patients with leptomeningeal disease [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Cheryl Ho, MD

604.877.6000cho@bccancer.bc.ca

Barbara Melosky, MD

604.877.6000

Locations

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Contacts

Cheryl Ho, MD

604-877-6000

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Feb 11, 2025

Last verified

Feb, 2025

Keywords

  • non-small cell lung cancer
  • EGFR
  • leptomeningeal disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2025-02-11.