Analyzing spinal fluid in lung cancer patients with leptomeningeal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial aims to evaluate the molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) in patients with EGFR mutant non-small cell lung cancer (NSCLC) who develop leptomeningeal disease. The study will involve 10 patients who will undergo lumbar puncture and blood sampling for molecular testing. Baseline quality of life assessments will be conducted, and follow-up questionnaires will be collected every 12 weeks. The trial will not involve any treatment intervention but will gather data on subsequent treatments received by participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• BC Cancer
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Cheryl Ho, MD — BC Cancer
• Study coordinator: Cheryl Ho, MD
• Email: cho@bccancer.bc.ca
• Phone: 604.877.6000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.