Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings
OBJECTIVES:
- Correlate changes in the level of serum tumor-specific DNA over time with changes in
brain tumor size as measured by serial MRI or CT scans in patients with grade III-IV
malignant gliomas.
OUTLINE: This is a multicenter study.
Blood samples are collected from patients at baseline and every 2 months thereafter. Tumor
and nontumor plasma is extracted. Plasma samples are analyzed by polymerase chain reaction
(PCR) to assess the p16_ink4a, p73, and O ^6-MGMT gene promoter methylation profile.
Quantitative realtime PCR is performed on samples with tumor-specific DNA to determine the
plasma concentrations of each methylated tumor-specific gene and the total plasma
tumor-specific DNA concentration. Patients also undergo MRI or CT scans every 2 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Interventional
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Total plasma glioma-specific DNA concentration
every 2 months until death
No
Stuart A. Grossman, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
NABTT-0402 CDR0000462562
NCT00897611
April 2005
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