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Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897611
First Posted: May 12, 2009
Last Update Posted: November 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
North American Brain Tumor Consortium
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose

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 Intervention
High Grade Glioma Procedure: DNA methylation analysis Procedure: polymerase chain reaction Procedure: computed tomography Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Total plasma glioma-specific DNA concentration [ Time Frame: every 2 months until death ]
  • Tumor size [ Time Frame: every 2 months until death ]

Enrollment: 42
Study Start Date: April 2005
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: DNA methylation analysis
    Other Name: blood collection
    Procedure: polymerase chain reaction
    Other Name: blood collection
    Procedure: computed tomography
    Other Name: CT scan
    Procedure: magnetic resonance imaging
    Other Name: MRI scan
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
North American Brain Tumor Consortium
Investigators
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
Principal Investigator: Kyle Weaver, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00897611     History of Changes
Other Study ID Numbers: NABTT-0402 CDR0000462562
U01CA062475 ( U.S. NIH Grant/Contract )
NABTT-0402
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
recurrent adult brain tumor
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue