Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma
|ClinicalTrials.gov Identifier: NCT00897611|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 30, 2012
RATIONALE: Studying levels of tumor DNA in the samples of blood from patients with cancer may help doctors find out whether the cancer has grown and how much.
PURPOSE: This laboratory study is comparing levels of tumor DNA with MRI and CT scan findings to measure cancer growth in patients with grade III or grade IV malignant glioma.
|Condition or disease||Intervention/treatment|
|High Grade Glioma||Procedure: DNA methylation analysis Procedure: polymerase chain reaction Procedure: computed tomography Procedure: magnetic resonance imaging|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings|
|Study Start Date :||April 2005|
|Primary Completion Date :||August 2009|
Procedure: DNA methylation analysis
- Total plasma glioma-specific DNA concentration [ Time Frame: every 2 months until death ]
- Tumor size [ Time Frame: every 2 months until death ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897611
|Study Chair:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center|
|Principal Investigator:||Kyle Weaver, MD||Vanderbilt-Ingram Cancer Center|