Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

May 16, 2025 updated by: Memorial Sloan Kettering Cancer Center

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
        • Contact:
          • Alexandra Miller, MD, PhD
          • Phone Number: 212-610-0783

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Potential research subjects will be identified by a member of the participant's treatment team, the protocol investigator, or research team at MSK. If the investigator is a member of the treatment team, s/he will screen their participant's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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 Names:
  • LP
Experimental: Cohort B
Cohort B will consist of patients with a histologically confirmed diagnosis of IDH WT glioblastoma.
Diagnostic test: 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 Names:
  • LP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Alexandra Miller, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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