10 Participants Needed

CSF Analysis for Non-Small Cell Lung Cancer

CH
BM
Overseen ByBarbara Melosky, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: British Columbia Cancer Agency
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is cerebrospinal fluid analysis safe for humans?

The research articles do not provide specific safety data for cerebrospinal fluid analysis, but this procedure, often involving a lumbar puncture (a needle inserted into the lower back to collect fluid), is generally considered safe with common side effects like headache or back pain.12345

How does the treatment involving lumbar puncture and phlebotomy differ from other treatments for non-small cell lung cancer?

This treatment is unique because it uses cerebrospinal fluid (CSF) obtained through lumbar puncture as a liquid biopsy to detect genetic mutations and tumor DNA in non-small cell lung cancer, especially in cases with leptomeningeal metastases. This approach provides a more comprehensive analysis of tumor genetics compared to traditional blood tests, offering a novel way to monitor and diagnose cancer spread to the central nervous system.26789

What data supports the effectiveness of the treatment Lumbar puncture and Phlebotomy for non-small cell lung cancer?

The research suggests that analyzing cerebrospinal fluid (CSF) through lumbar puncture can help identify genetic mutations and guide treatment decisions for non-small cell lung cancer (NSCLC) patients with central nervous system metastases. This approach can potentially improve treatment strategies and outcomes by providing valuable information about the cancer's genetic profile.12367

Who Is on the Research Team?

CH

Cheryl Ho, MD

Principal Investigator

BC Cancer

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific lung cancer (EGFR mutant NSCLC) that has spread to the lining of the brain and spinal cord. They must be able to consent, have a life expectancy of at least 8 weeks, and their body should be functioning well enough for testing. People can't join if they have bleeding issues or conditions preventing safe lumbar puncture.

Inclusion Criteria

My lung cancer has a specific EGFR mutation and has spread.
Ability to give informed consent for the study procedures defined in this protocol.
Life expectancy of at least 8 weeks.
See 3 more

Exclusion Criteria

Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
I cannot have a lumbar puncture due to low platelets, bleeding issues, or cannot consent.
My MRI shows a condition in my spine that makes lumbar puncture unsafe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline MRI brain and spine must be completed, and baseline quality of life questionnaires are collected

1-2 weeks
1 visit (in-person)

Molecular Testing

ddPCR and BC Cancer NGS panel completed on cerebral spinal fluid and blood circulating tumor DNA

Ongoing
Every 12 weeks +/- 2 weeks

Follow-up

Participants are monitored for overall survival and quality of life, with assessments every 12 weeks

36 months
Every 12 weeks +/- 2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lumbar puncture and Phlebotomy
Trial Overview The study aims to find molecular differences between tumor DNA in cerebral spinal fluid (CSF) and blood in patients with leptomeningeal disease from lung cancer. It involves comparing CSF obtained by lumbar puncture with blood samples using advanced molecular tests.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Experimental armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials
181
Recruited
95,900+

Published Research Related to This Trial

In a study of 30 patients with advanced non-small-cell lung cancer (NSCLC), those diagnosed with cerebrospinal fluid (CSF) metastasis showed significantly higher frequencies of EGFR mutations (80%) and ALK fusions (50%) compared to a control group without CSF metastasis.
Patients with CSF metastasis had a median survival time of only 4.8 months, which is notably shorter than the 9.2 months median survival for those without CSF metastasis, indicating that gene mutations may not only increase the incidence of CSF metastasis but also worsen prognosis.
The relationship between cerebrospinal fluid metastasis and gene mutations in non-small-cell lung cancer patients.Ji, X., Du, Y., Liu, Y., et al.[2020]
Cerebrospinal fluid (CSF) cell-free DNA (cfDNA) was found to be a highly effective source for detecting genetic mutations in patients with leptomeningeal metastases (LM) from non-small-cell lung cancer (NSCLC), with 100% detection of driver genes in CSF cfDNA samples.
The study revealed that CSF cfDNA not only captured unique genetic profiles compared to plasma and primary tumor samples but also showed a significantly higher frequency of copy number variations and loss of heterozygosity in key genes like TP53, indicating its potential as a superior liquid biopsy medium for monitoring LM in patients with EGFR mutations.
Unique genetic profiles from cerebrospinal fluid cell-free DNA in leptomeningeal metastases of EGFR-mutant non-small-cell lung cancer: a new medium of liquid biopsy.Li, YS., Jiang, BY., Yang, JJ., et al.[2020]
A study analyzing cerebrospinal fluid (CSF) from 46 patients with leptomeningeal metastases from non-small cell lung cancer (NSCLC) identified six potential biomarkers, including tyrosine and phenylalanine, which could help in diagnosing this condition.
The research utilized advanced metabolomic techniques and found that these biomarkers are linked to key metabolic pathways, such as glycolysis and amino acid metabolism, suggesting their role in the disease's development.
Untargeted metabolomics analysis of cerebrospinal fluid in patients with leptomeningeal metastases from non-small cell lung cancer.Li, H., Lin, Y., Zheng, S., et al.[2023]

Citations

The relationship between cerebrospinal fluid metastasis and gene mutations in non-small-cell lung cancer patients. [2020]
Unique genetic profiles from cerebrospinal fluid cell-free DNA in leptomeningeal metastases of EGFR-mutant non-small-cell lung cancer: a new medium of liquid biopsy. [2020]
Untargeted metabolomics analysis of cerebrospinal fluid in patients with leptomeningeal metastases from non-small cell lung cancer. [2023]
Genomic Alterations Identification and Resistance Mechanisms Exploration of NSCLC With Central Nervous System Metastases Using Liquid Biopsy of Cerebrospinal Fluid: A Real-World Study. [2022]
Prognostic significance of molecular characteristics of cerebrospinal fluid for non-small cell lung cancer patients with leptomeningeal metastasis. [2020]
Unique Genomic Alterations of Cerebrospinal Fluid Cell-Free DNA Are Critical for Targeted Therapy of Non-Small Cell Lung Cancer With Leptomeningeal Metastasis. [2021]
Afatinib for Advanced Non-small Cell Lung Cancer in a Case With an Uncommon Epidermal Growth Factor Receptor Mutation (G719A) Identified in the Cerebrospinal Fluid. [2023]
Cerebrospinal fluid-derived circulating tumor DNA is more comprehensive than plasma in NSCLC patients with leptomeningeal metastases regardless of extracranial evolution. [2023]
Cerebrospinal fluid cytology diagnosis of meningeal carcinomatosis in patients with small-cell carcinoma of the lung. A study of interobserver and intraobserver variability. [2006]
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