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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOhio State University Comprehensive Cancer Center

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Lumbar Puncture

    Procedure/Surgery

    Undergo LP

  • Magnetic Resonance Imaging

    Device

    Undergo MRI

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Stage III/IV without brain metastases (LP)Experimental treatment 3 interventions
Group B: Cohort 2: Stage IV NSCLC with brain metastases (LP)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of subjects with Intracranial disease in locally advanced lung cancer patients

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.

Time frame
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

Will estimate the frequency of ctDNA detection with a 90% Clopper-Pearson confidence interval.

Time frame
Up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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