cropped color_logo_with_background.png

Clinical Trial Finder

Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05927610
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alexandra Miller, MD, PhD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Withdrawn
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

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.

Experimental: Cohort B

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

Interventions

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).

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Powered By