NCT05257967Recruiting
CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease
CSF Liquid Biopsy Based Characterization of Leptomeningeal Disease in EGFR Mutant Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 5 Feb 2022
- Start date
- 18 Jul 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- British Columbia Cancer Agency
- Diseases
- Lung cancer
- NCT number
- NCT05257967
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 18 Jul 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.
- MRI spine demonstrating spinal leptomeningeal disease preventing a safe lumbar puncture.
Other
- Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Cancer Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.