Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05927610

Enrollment

Registered

2023-07-03

Start date

2023-06-19

Completion date

2024-02-15

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Keywords

Glioblastoma, CSF cfDNA, cerebrospinal fluid cell free DNA, Memorial Sloan Kettering Cancer Center, 23-058

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).

Interventions

DIAGNOSTIC_TESTLumber 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).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026