Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

Study Overview
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Brief Summary
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The goal of this study is to determine the utility of cerebrospinal fluid (CSF) cell-free DNA (cfDNA) as a prognostic biomarker in glioblastoma (GBM).

Official Title
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Evaluating the Role of Cerebrospinal Fluid (CSF) Cell-free DNA (cfDNA) as a Prognostic Biomarker in Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Diagnostic Test: Lumber Puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cohort A Participants must be able to understand and be willing to sign a written informed consent document Age ≥ 18 years MRI with contrast-enhancing lesion concerning for high-grade glioma in absence of known systemic malignancy Clinical consensus of presumed diagnosis of high grade glioma between (1) neuroradiology (2) neurosurgery; and (3) principal investigator No prior tumor directed therapy Planned radiation therapy for glioblastoma Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast Patients must be willing to consent to MSK IRB#12-245 Cohort B Participants must be able to understand and be willing to sign a written informed consent document Age ≥ 18 years Histologic confirmed glioblastoma (WHO grade IV), IDH wild type per IHC No prior tumor-directed therapies except surgical resection or biopsy Patients who have gliadel wafers placed during upfront surgery are excluded Planned radiation therapy for glioblastoma Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast Patients must be willing to consent to MSK IRB#12-245 Exclusion Criteria: Cohorts A and B Any case for which there is a medical contraindication or safety concern regarding a lumbar puncture under standard medical guidelines at MSK Refusal to undergo serial lumbar punctures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Cohort A will consist of newly diagnosed patients with Glioblastoma. Eligibility for enrollment prior to pathology diagnosis will be determined by a consensus diagnosis of high grade glioma based on clinical and radiographic evidence between neuroradiologist, neurosurgeon and study PI. | Diagnostic Test: Lumber Puncture<br>* During the lumbar puncture/LP, 20cc will be collected per standard practice in adult patients. LP will be performed either at bedside or under interventional radiology (IR) guidance (due to patient anatomy).<br>* Other names: LP;|
| Cohort B<br>Cohort B will consist of patients with a histologically confirmed diagnosis of IDH WT glioblastoma. | Diagnostic Test: Lumber Puncture<br>* During the lumbar puncture/LP, 20cc will be collected per standard practice in adult patients. LP will be performed either at bedside or under interventional radiology (IR) guidance (due to patient anatomy).<br>* Other names: LP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival will be calculated as the time from pathological diagnosis to the date of death due to any cause (prior to analysis cut-off) or last follow-up | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma, CSF cfDNA, cerebrospinal fluid cell free DNA, Memorial Sloan Kettering Cancer Center, 23-058