Analyzing spinal fluid in lung cancer patients with leptomeningeal disease
CSF Liquid Biopsy Based Characterization of Leptomeningeal Disease in EGFR Mutant Non-Small Cell Lung Cancer
This study is trying to see how the spinal fluid and blood of lung cancer patients with a specific mutation differ, to better understand their condition and how it affects their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05257967 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic EGFR mutant NSCLC and leptomeningeal disease.
Not a fit: Patients who cannot undergo a lumbar puncture or have conditions preventing safe participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective targeted therapies for patients with leptomeningeal disease in EGFR mutant NSCLC.
How similar studies have performed: While this approach is novel in the context of leptomeningeal disease in NSCLC, similar molecular profiling studies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.