Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

NCT05927610 | Withdrawn

• 1 other identifier: 23-058
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Glioblastoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort A

EXPERIMENTAL

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

Cohort B

EXPERIMENTAL

Cohort B will consist of patients with a histologically confirmed diagnosis of IDH WT glioblastoma.

Diagnostic Test: Lumber Puncture

Interventions

Lumber Puncture DIAGNOSTIC_TEST

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).

Also known as: LP

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Alexandra Miller, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 3, 2023
• Study Start: June 19, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share