Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma
NCT ID: NCT05927610
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-06-19
2024-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort A
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.
Lumber Puncture
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).
Cohort B
Cohort B will consist of patients with a histologically confirmed diagnosis of IDH WT glioblastoma.
Lumber Puncture
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).
Interventions
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Lumber Puncture
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Alexandra Miller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-058
Identifier Type: -
Identifier Source: org_study_id
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