Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

Memorial Sloan Kettering Cancer Center (MSK)

Status: Withdrawn

Conditions: Glioblastoma

Treatments: Diagnostic Test: Lumber Puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05927610

23-058

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Cohort A

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Lumber Puncture

Cohort B

Experimental group

Description:

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

Treatment:

Diagnostic Test: Lumber Puncture