NCT00897611

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

4.3 years

First QC Date

May 9, 2009

Last Update Submit

November 29, 2012

Conditions

High Grade Glioma

Keywords

adult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult giant cell glioblastomarecurrent adult brain tumoradult glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (2)

  • Total plasma glioma-specific DNA concentration

    every 2 months until death

  • Tumor size

    every 2 months until death

Interventions

DNA methylation analysisPROCEDURE
Also known as: blood collection
polymerase chain reactionPROCEDURE
Also known as: blood collection
computed tomographyPROCEDURE
Also known as: CT scan
magnetic resonance imagingPROCEDURE
Also known as: MRI scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

GliomaAstrocytomaOligodendrogliomaGlioblastomaBrain NeoplasmsGliosarcoma

Interventions

DNA MethylationBlood Specimen CollectionPolymerase Chain ReactionMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesNucleic Acid Amplification TechniquesGenetic TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Stuart A. Grossman, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

  • Kyle Weaver, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2005

Primary Completion

August 1, 2009

Last Updated

November 30, 2012

Record last verified: 2012-11