Status:
RECRUITING
CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer with Leptomeningeal Disease
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
EGFR Activating Mutation
Leptomeningeal Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
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 leptomeni...
Detailed Description
The aim of this pilot trial is to evaluate the concordance/discordance of molecular profiling of CSF and plasma ctDNA after the development of leptomeningeal disease in EGFR mutant NSCLC. Patients wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05257967
Start Date
July 18 2022
End Date
December 31 2026
Last Update
February 11 2025
Active Locations (1)
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1
BC Cancer
Vancouver, British Columbia, Canada, V5Z4E6