Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05927610

Collaborator

(none)

180

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Diagnostic Test: Lumber Puncture

Study Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 19, 2023

Anticipated Primary Completion Date :

Jun 19, 2028

Anticipated Study Completion Date :

Jun 19, 2028

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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:

Cohort B

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

Diagnostic Test: Lumber Puncture

Other Names:

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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