Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Non-Small Cell Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage III Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Lumbar Puncture | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: Stage III/IV without brain metastases (LP)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Lumbar Puncture
- Device: Magnetic Resonance Imaging
- type
- EXPERIMENTAL
- label
- Cohort 2: Stage IV NSCLC with brain metastases (LP)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the medication and radiation required for standard of care treatment has unknown effects on the unborn fetus
References
Publications (0)
Data not yet available