Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III… (NCT06816979) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer
United States40 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects with Intracranial disease in locally advanced lung cancer patients
Timeframe: Up to 6 months
2
Cerebral spinal fluid- circulating tumor deoxyribonucleic acid (ctDNA) detection rate for lung non-small cell carcinoma patients with metastatic disease to the brain
Timeframe: Up to 12 months
Trial details
NCT IDNCT06816979
SponsorOhio State University Comprehensive Cancer Center