Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer
Assessing the CSF-ctDNA of Patients With Stage III and IV Non-Small Cell Lung Cancer: A Pilot Study
2 other identifiers
interventional
40
1 country
1
Brief Summary
This phase I trial assesses the use of lumbar punctures to detect whether there is circulating tumor deoxyribonucleic acid (ctDNA) in the fluid that surrounds the brain and spinal cord (cerebrospinal fluid) in patients with stage III and IV non-small cell lung cancer (NSCLC). Patients with stage III and IV NSCLC are at risk of having their cancer spread from where it first started to the brain (metastatic). Because of this, more effective prognostic tools are necessary to determine which stage III and IV NSCLC patients are more likely to develop brain metastases. Cerebrospinal fluid (CSF) could be a reliable source of ctDNA to confirm and predict the presence of brain metastases in these patients. Assessing cell free DNA shed from tumor cells could be a sensitive and minimally invasive way to detect or characterize metastatic tumors in the central nervous system (CNS). Lumbar puncture is procedure in which a thin needle called a spinal needle is put into the lower part of the spinal column to collect CSF. Lumbar punctures for the collection of CSF may help doctors detect or measure changes in cell types, genes, and proteins of circulating tumor cells related to lung cancer that will help determine the presence of brain metastases which could become a standard of care screening tool utilized in the follow-up of patients diagnosed with stage II or IV NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2025
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
Study Completion
Last participant's last visit for all outcomes
January 31, 2028
April 8, 2026
April 1, 2026
1.4 years
November 4, 2023
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of subjects with Intracranial disease in locally advanced lung cancer patients
An MRI will be performed six months after lumbar puncture in Cohort One. MRI sequences with T1 post-contrast for disease and structure definition and T2/FLAIR sequences for identification of peri-tumoral edema or cystic volumes will be obtained.
Up to 6 months
Cerebral spinal fluid- circulating tumor deoxyribonucleic acid (ctDNA) detection rate for lung non-small cell carcinoma patients with metastatic disease to the brain
Will estimate the frequency of ctDNA detection with a 90% Clopper-Pearson confidence interval.
Up to 12 months
Study Arms (2)
Cohort 1: Stage III/IV without brain metastases (LP)
EXPERIMENTALPatients undergo LP for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo MRI during screening and 12 month follow-up. Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
Cohort 2: Stage IV NSCLC with brain metastases (LP)
EXPERIMENTALPatients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening. Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
Interventions
Undergo blood sample collection
Undergo LP
Undergo MRI
Eligibility Criteria
You may qualify if:
- New histological diagnosis of stage III or IV NSCLC
- For stage III/IV NSCLC patients without brain metastases, a documented mutation on lung cancer mutation panel (PULMOL) is required
- Patient treated with radiation therapy and/or systemic therapy at Ohio State University
- Estimated survival \>= 1 year
- No medical contraindication to lumbar puncture
You may not qualify if:
- Patient has Alzheimer's, dementia, or mental disability
- Patient is not able to receive MRI
- Patient has allergy to xylocaine or any numbing medication for lumbar puncture
- Previous cancer history prior to diagnosis of NSCLC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua D Palmer, MD
Ohio State University Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2023
First Posted
February 10, 2025
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share