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

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00897611

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
Brain and Central Nervous System Tumors	Genetic: DNA methylation analysis Genetic: polymerase chain reaction Procedure: computed tomography Procedure: magnetic resonance imaging

Study Type:	Observational
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:

MedlinePlus related topics: CT Scans Cancer MRI Scans Nuclear Scans

Drug Information available for: Deoxyribonucleic acid

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Total plasma glioma-specific DNA concentration [ Designated as safety issue: No ]
Tumor size [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2005
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897611

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:	Stuart A. Grossman, MD	Sidney Kimmel Comprehensive Cancer Center
Investigator:	Kyle Weaver, MD	Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00897611 History of Changes
Other Study ID Numbers:	CDR0000462562, NABTT-0402
Study First Received:	May 9, 2009
Last Updated:	August 21, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma

recurrent adult brain tumor
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms by Site
Neoplasms
Nervous System Diseases

Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 23, 2012