Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma
NCT ID: NCT00897611
Last Updated: 2012-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2005-04-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Interventions
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DNA methylation analysis
polymerase chain reaction
computed tomography
magnetic resonance imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed malignant brain tumor
* One of the following grade III or IV supratentorial gliomas:
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Glioblastoma multiforme
* Newly diagnosed or recurrent disease
* Planning to undergo anticancer therapy on a New Approaches to Brain Tumor Therapy (NABTT) Consortium clinical trial
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
North American Brain Tumor Consortium
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Stuart A. Grossman, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Kyle Weaver, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Other Identifiers
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NABTT-0402
Identifier Type: -
Identifier Source: secondary_id
NABTT-0402 CDR0000462562
Identifier Type: -
Identifier Source: org_study_id