High Grade GliomaNCT00897611
Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma
A study testing DNA methylation analysis, polymerase chain reaction and computed tomography in people with High Grade Glioma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- DNA methylation analysis, polymerase chain reaction and computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings
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.
Read the 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.
- Conditions
- High Grade Glioma
- Being tested
- DNA methylation analysis, polymerase chain reaction, computed tomography, magnetic resonance imaging
- Keywords
- adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma, Brain Neoplasms, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation analysisProcedure or surgery
Also called blood collection
polymerase chain reactionProcedure or surgery
Also called blood collection
computed tomographyProcedure or surgery
Also called CT scan
magnetic resonance imagingProcedure or surgery
Also called MRI scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Total plasma glioma-specific DNA concentration
Measured: every 2 months until death
Tumor size
Measured: every 2 months until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2005
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), North American Brain Tumor Consortium
- Responsible party
- Sponsor
- Investigators
- Stuart A. Grossman, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsKyle Weaver, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897611
- Sponsor's protocol ID
- NABTT-0402 CDR0000462562
- Other IDs
- U01CA062475, NABTT-0402
- Status last verified
- Nov 2012
- First submitted
- 9 May 2009
- Last updated
- 30 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings
- ClinicalTrials.gov ID
- NCT00897611
- Acronym / sponsor ID
- NABTT-0402 CDR0000462562
- Conditions
- High Grade Glioma
- Keywords
- adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), North American Brain Tumor Consortium
- Study start
- Apr 2005
- Primary completion
- Aug 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA methylation analysisAlso: blood collection | Procedure or surgery | – |
| polymerase chain reactionAlso: blood collection | Procedure or surgery | – |
| computed tomographyAlso: CT scan | Procedure or surgery | – |
| magnetic resonance imagingAlso: MRI scan | Procedure or surgery | – |
Primary outcome
Total plasma glioma-specific DNA concentration
Time frame: every 2 months until death
Tumor size
Time frame: every 2 months until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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Malignant Glioma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart A. Grossman, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Kyle Weaver, MD principal investigator
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing DNA methylation analysis, polymerase chain reaction and computed tomography in people with High Grade Glioma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total plasma glioma-specific DNA concentration (time frame: every 2 months until death). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.