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NCT05927610 Clinical Trial

Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05927610
Other study ID # 23-058
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 19, 2023
Est. completion date February 15, 2024

Study information
Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 15, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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