About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Lumbar Puncture
  • Magnetic Resonance Imaging

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

1
Ohio State University Comprehensive Cancer Center43210, ColumbusOhio, United States

Sponsors and collaborators

Ohio State University Comprehensive Cancer Center

Lead sponsor