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Diagnostic Test

CSF Analysis for Non-Small Cell Lung Cancer

N/A

Recruiting

Led By Cheryl Ho, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

This trial is evaluating a way to find out if systemic therapy is more effective if it can target the correct molecular aberration by looking at molecular differences between cerebral spinal fluid and blood circulating tumor DNA.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are related to the procedures: lumbar puncture might cause back pain, headache, or risk of infection; phlebotomy may result in bruising or discomfort at the needle site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My lung cancer has a specific EGFR mutation and has spread.

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My blood and organs are functioning well enough for tests.

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I can care for myself but may not be able to do heavy physical work.

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My cancer has spread to the lining of my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concordance of molecular profiling of CSF and plasma in EGFR mutation positive NSCLC patients with leptomeningeal disease

Secondary outcome measures

Concordance of treatment recommendations based on ctDNA and CSF

Correlation between MRI and CSF

Molecular profiling comparison

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental armExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

90,501 Total Patients Enrolled

Cheryl Ho, MDPrincipal InvestigatorBC Cancer

4 Previous Clinical Trials

1,661 Total Patients Enrolled

Media Library

Lumbar puncture and Phlebotomy (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05257967 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Experimental arm

Non-Small Cell Lung Cancer Clinical Trial 2023: Lumbar puncture and Phlebotomy Highlights & Side Effects. Trial Name: NCT05257967 — N/A

Lumbar puncture and Phlebotomy (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05257967 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for new participants to join this clinical experiment?

"As outlined on clinicaltrials.gov, this investigation is still recruiting participants. The original post was made on July 18th 2022 and the entry has been updated as recently as that same date."

Answered by AI

To what extent is this experiment being conducted with human subjects?

"Affirmative. Clinicaltrials.gov shows that the study, which was initially posted on July 18th 2022 and most recently amended on July 18th 2022, is actively seeking participants for its trial with 10 individuals being recruited from a single medical centre."

Answered by AI

Recent research and studies

JAMA Network OpenJournal

Detection of Leptomeningeal Disease Using Cell-free DNA from Cerebrospinal Fluid

White, Michael D., Robert H. Klein, Brian Shaw, Albert Kim, Megha Subramanian, Joana L. Mora, Anita Giobbie-Hurder, et al.. 2021. “Detection of Leptomeningeal Disease Using Cell-free DNA from Cerebrospinal Fluid”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.20040.

Neuro-OncologyJournal

A Retrospective, Quantitative Assessment of Disease Burden in Patients with Leptomeningeal Metastases from Non-small-cell Lung Cancer

Nevel, Kathryn S, Natalie DiStefano, Xuling Lin, Anna Skakodub, Shahiba Q Ogilvie, Anne S Reiner, Elena Pentsova, and Adrienne Boire. 2019. “A Retrospective, Quantitative Assessment of Disease Burden in Patients with Leptomeningeal Metastases from Non-small-cell Lung Cancer”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/noz208.

clinicaltrials.govStudy

CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease

Cheryl 2022. "CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05257967.