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

Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00897611

Enrollment

Registered

2009-05-12

Start date

2005-04-30

Completion date

Unknown

Last updated

2012-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Grade Glioma

Keywords

adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma

Brief summary

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.

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.

Interventions

PROCEDUREDNA methylation analysis

PROCEDUREpolymerase chain reaction

PROCEDUREcomputed tomography

PROCEDUREmagnetic resonance imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Total plasma glioma-specific DNA concentration	every 2 months until death
Tumor size	every 2 months until death

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026