Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06816979
Status
Not Yet Recruiting

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Conditions

  • Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Lumbar Puncture — PROCEDURE
    Undergo LP
  • Magnetic Resonance Imaging — DEVICE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Sep 15, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Cohort 1: Stage III/IV without brain metastases (LP)
    Patients 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.
  • Experimental: Cohort 2: Stage IV NSCLC with brain metastases (LP)
    Patients 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.

Primary Outcome Measure

Number of subjects with Intracranial disease in locally advanced lung cancer patients [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Joshua D. Palmer, MD
[email protected]
614-293-0871
Joshua D. Palmer, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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