CSF Liquid Biopsy Based Characterization of Leptomeningeal Disease in EGFR Mutant Non-Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
BC Cancer
RECRUITING
Vancouver
Contact Information
Primary
Cheryl Ho, MD
cho@bccancer.bc.ca
604.877.6000
Backup
Barbara Melosky, MD
604.877.6000
Time Frame
Start Date: 2022-07-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Experimental arm
ddPCR and BC Cancer NGS panel completed on cerebral spinal fluid and blood circulating tumor DNA
Sponsors
Leads: British Columbia Cancer Agency

This content was sourced from clinicaltrials.gov

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