Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma
Not Applicable
Withdrawn
- Conditions
- Glioblastoma
- Registration Number
- NCT05927610
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall Survival 6 months 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
- Secondary Outcome Measures
Name Time Method