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NCT06816979 · ClinicalTrials.gov registry record · NA
Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer
A NA study, sponsored by Ohio State University Comprehensive Cancer Center.
- Not yet
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT06816979: Clinical Trial NA study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT06816979 is a NA study that has not yet begun recruiting, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06816979, a NA study, has not yet begun recruiting, sponsored by Ohio State University Comprehensive Cancer Center.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Lumbar Puncture
- DEVICE Magnetic Resonance Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-09-15 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
What is known before NCT06816979 opens enrollment
NCT06816979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT06816979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06816979 about?
NCT06816979 is a clinical study titled "Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer". 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...
What is the current status of trial NCT06816979?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-09-15. Estimated completion is 2028-01-31.
What interventions are being tested in trial NCT06816979?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (DEVICE).
Who is sponsoring clinical trial NCT06816979?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06816979's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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