Detection of Leptomeningeal Disease Using Cell-Free DNA From Cerebrospinal Fluid.
Michael D White, Robert H Klein, Brian Shaw...
https://pubmed.ncbi.nlm.nih.gov/34369989Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05257967
CSF Liquid Biopsy Based Characterization of Leptomeningeal Disease in EGFR Mutant Non-Small Cell Lung Cancer
Led by British Columbia Cancer Agency · Updated on 2025-02-11
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Leptomeningeal disease occurs when cancer cells spread to the membranes around the brain and spinal cord, causing symptoms that often affect quality of life. This condition is increasingly common in patients with EGFR mutant non-small cell lung cancer (NSCLC). The research aims to study molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) in these patients to better understand the disease. The study involves analyzing CSF and plasma samples from patients with EGFR mutant NSCLC who develop leptomeningeal disease while on tyrosine kinase inhibitor treatment. Molecular testing using ddPCR and the BC Cancer Next-Generation Sequencing panel will be performed on these samples. There is no treatment given in the trial; instead, patients will continue their usual care while researchers collect detailed molecular and imaging data. Participants will undergo baseline brain and spine MRI scans to ensure lumbar puncture safety before enrollment. Quality of life questionnaires will be completed every 12 weeks, and survival data will be collected through chart review. The study measures the agreement between molecular profiles from CSF and plasma, treatment recommendations, MRI findings, survival, and quality of life over a 36-month period. The total study participation duration depends on each patient's timeline during this period.
CONDITIONS
Brief Title
CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically or cytologically confirmed metastatic EGFR mutant non-small cell lung cancer
- Diagnosis of leptomeningeal disease based on brain MRI or CSF cytology
- ECOG performance status between 0 and 3
- Life expectancy of at least 8 weeks
- Adequate blood and organ function for testing
- Ability to provide informed consent for study procedures
You will not qualify if you...
- Unable to undergo lumbar puncture due to low platelets, bleeding problems, inability to cooperate, or inability to consent
- Deemed unfit to proceed with the study by the treating clinician
- Spinal leptomeningeal disease on MRI that prevents a safe lumbar puncture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline MRI brain and spine to ensure lumbar puncture can be safely completed
Diagnostic Evaluation
Duration - Baseline visit and ongoing assessments every 12 weeks
Participants undergo lumbar puncture and blood draws for molecular testing of cerebrospinal fluid and plasma to characterize leptomeningeal disease.
Baseline visit plus visits every 12 weeks (+/- 2 weeks) for quality of life questionnaires and sample collection
Long-term Monitoring
Duration - Up to 36 months
Participants are monitored through chart review to assess survival and disease progression without any treatment intervention from the trial.
Ongoing data collection from medical records; no additional visits required
Trial Site Locations
Total: 1 location
1
BC Cancer
Vancouver, British Columbia, Canada, V5Z4E6
Actively Recruiting
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Research Team
C
Cheryl Ho, MD
B
Barbara Melosky, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
A retrospective, quantitative assessment of disease burden in patients with leptomeningeal metastases from non-small-cell lung cancer.
Kathryn S Nevel, Natalie DiStefano, Xuling Lin...
https://pubmed.ncbi.nlm.nih.gov/32352148