Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma
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|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||Phase|
|High Grade Glioma||Procedure: DNA methylation analysis Procedure: polymerase chain reaction Procedure: computed tomography Procedure: magnetic resonance imaging||Not Applicable|
- 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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897611
|Study Chair:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Principal Investigator:||Kyle Weaver, MD||Vanderbilt-Ingram Cancer Center|