GliomaNCT00031538
Genetic Analysis of Brain Tumors
An observational study of Glioma and Glioblastoma Multiforme, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
This study will analyze tissue and blood samples from patients with gliomas (a type of brain tumor) to develop a new classification system for these tumors. Tumor classification can help guide treatment, in part by predicting how aggressive a tumor may be. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
- How many people
- 674 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2002to 29 Apr 2015
- Phase
- Observational
- 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 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- ELIGIBILITY CRITERIA:
Any patient with radiographic suggestion of a primary glial neoplasm or any patient with a known glial neoplasm.
Medically indicated (diagnostic and/or therapeutic) tumor resection, or biopsy.
Informed consent from patient or parents of children under the age of 18 years old. Patients or parents of children under the age of 18 must sign an authorization for the release of their protected health information.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Columbia University
New York, New York, 10032-3784
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-6541
About this study
Official title: A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas: The Glioma Molecular Diagnostic Initiative
This study will analyze tissue and blood samples from patients with gliomas (a type of brain tumor) to develop a new classification system for these tumors. Tumor classification can help guide treatment, in part by predicting how aggressive a tumor may be. Gliomas are currently classified according to their grade (how quickly they may grow) and the type of cells they are composed of. This system, however, is not always accurate, and sometimes two tumors that appear to be identical under the microscope will have very different growth patterns and responses to treatment. The new classification system is based on tumor genes and proteins, and may be used in the future to better predict a given tumor s behavior and response to therapy.
Patients with evidence of a primary brain tumor and patients with a known glioma who will be undergoing surgery to remove the tumor may participate in this study.
A sample of tumor tissue removed in the course of a participant s normal clinical care will be used in this study for laboratory analysis of genes and chromosome abnormalities. A small blood sample will also be collected for genetic analysis. In addition, clinical information on patients condition and response to treatment will be collected every 6 months over several years. This information will include findings from physical and neurologic examinations, radiographic findings, and response to therapy, including surgery, radiation and chemotherapy.
Read the detailed description
Background:
Primary brain tumors are an increasingly important cause of cancer-related morbidity and mortality in this country. Little progress has been made in the treatment of patients with gliomas over the last decade. One of the largest problems in our understanding, and ultimately in our successful treatment of gliomas is the great heterogeneity between tumors.
Objective:
The purpose of this study is to generate a large publicly accessible molecular and genetic database with prospective corollary clinical data for 1000 gliomas for the purpose of allowing investigators from around the world to ask important questions regarding the pathogenesis of these tumors, the development of novel molecular classification schemas, and the identification of potentially new and important therapeutic targets.
To substantially enlarge the growing glioma genomic and corollary clinical database currently being generated by the Glioma Molecular Diagnostic Initiative (GMDI) and recorded in the Repository of Malignant Brain Tumor Database (REMBRANDT), through the accrual of any potential glioma patient with banked formalin-fixed, paraffin-embedded (FFPE) tissue blocks rather than restricting accrual to only those patients undergoing surgical resection of their tumor. (NCI Only)
Cell lines will be created using glioma tissue harvested during surgery. The cell lines will be used for research in the NOB laboratory as well as to advance the public s scientific knowledge by making them available to intramural, extramural and private sector investigators for their own research. This would be done after executing a Material Transfer Agreement (MTA) as needed on a case by case basis. The PI of this study should be contacted directly for initiation of a cell line transfer to another organization or investigator. (NCI Only)
Eligibility:
Any patient with radiographic suggestion of a primary glial neoplasm or any patient with a known glial neoplasm.
Medically indicated (diagnostic and/or therapeutic) tumor resection, or biopsy.
Design:
All attempts will be made to obtain specimens immediately adjacent to the areas of resection taken for "permanent sections" in order to optimize the likelihood that the tumor seen on permanent sections is representative of that taken for genetic analysis.
Once tumor specimens have been acquired, they will be immediately brought to a liquid nitrogen cell/tissue storage container, -70/-80 degrees C, or -20 degrees C freezer (in order of preference) for storage.
Following storage of the specimens, the NCI-based study specimen coordinator will be contacted for determination of when frozen specimens will be sent to the NCI for analysis.
10 ml of whole blood will be obtained for analysis of SNP Analogs.
Patients will be evaluated every 6 months at a minimum.
A total of 1000 patients will be enrolled.
- Keywords
- Brain Tumor, Surgery, Molecular, Glioma, Intraoperative, Gliomas
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To generate a large publicly accessible molecular and genetic data base with prospective corollary clinical data for 1000 gliomas
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2002 (estimated)
- Study start1 Mar 2002
- Study completion29 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ronald E Gress, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031538
- Sponsor's protocol ID
- 020140
- Other IDs
- 02-C-0140
- Status last verified
- 29 Apr 2015
- First submitted
- 6 Mar 2002
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, et al. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. doi: 10.1200/JCO.1993.11.5.850.
PubMed 8487049Cairncross JG, Macdonald DR. Successful chemotherapy for recurrent malignant oligodendroglioma. Ann Neurol. 1988 Apr;23(4):360-4. doi: 10.1002/ana.410230408.
PubMed 3382171Fine HA. The basis for current treatment recommendations for malignant gliomas. J Neurooncol. 1994;20(2):111-20. doi: 10.1007/BF01052722.
PubMed 7807189
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas: The Glioma Molecular Diagnostic Initiative
- ClinicalTrials.gov ID
- NCT00031538
- Acronym / sponsor ID
- 020140
- Keywords
- Brain Tumor, Surgery, Molecular, Glioma, Intraoperative, Gliomas
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 674 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Mar 2002
- Study completion
- 29 Apr 2015
- First posted
- 7 Mar 2002 (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.
This study will analyze tissue and blood samples from patients with gliomas (a type of brain tumor) to develop a new classification system for these tumors. Tumor classification can help guide treatment, in part by predicting how aggressive a tumor may be. Gliomas are currently classified according to their grade (how quickly they may grow) and the type of cells they are composed of. This system, however, is not always accurate, and sometimes two tumors that appear to be identical under the microscope will have very different growth patterns and responses to treatment. The new classification system is based on tumor genes and proteins, and may be used in the future to better predict a given tumor s behavior and response to therapy.
Patients with evidence of a primary brain tumor and patients with a known glioma who will be undergoing surgery to remove the tumor may participate in this study.
A sample of tumor tissue removed in the course of a participant s normal clinical care will be used in this study for laboratory analysis of genes and chromosome abnormalities. A small blood sample will also be collected for genetic analysis. In addition, clinical information on patients condition and response to treatment will be collected every 6 months over several years. This information will include findings from physical and neurologic examinations, radiographic findings, and response to therapy, including surgery, radiation and chemotherapy.
Detailed description
Background:
Primary brain tumors are an increasingly important cause of cancer-related morbidity and mortality in this country. Little progress has been made in the treatment of patients with gliomas over the last decade. One of the largest problems in our understanding, and ultimately in our successful treatment of gliomas is the great heterogeneity between tumors.
Objective:
The purpose of this study is to generate a large publicly accessible molecular and genetic database with prospective corollary clinical data for 1000 gliomas for the purpose of allowing investigators from around the world to ask important questions regarding the pathogenesis of these tumors, the development of novel molecular classification schemas, and the identification of potentially new and important therapeutic targets.
To substantially enlarge the growing glioma genomic and corollary clinical database currently being generated by the Glioma Molecular Diagnostic Initiative (GMDI) and recorded in the Repository of Malignant Brain Tumor Database (REMBRANDT), through the accrual of any potential glioma patient with banked formalin-fixed, paraffin-embedded (FFPE) tissue blocks rather than restricting accrual to only those patients undergoing surgical resection of their tumor. (NCI Only)
Cell lines will be created using glioma tissue harvested during surgery. The cell lines will be used for research in the NOB laboratory as well as to advance the public s scientific knowledge by making them available to intramural, extramural and private sector investigators for their own research. This would be done after executing a Material Transfer Agreement (MTA) as needed on a case by case basis. The PI of this study should be contacted directly for initiation of a cell line transfer to another organization or investigator. (NCI Only)
Eligibility:
Any patient with radiographic suggestion of a primary glial neoplasm or any patient with a known glial neoplasm.
Medically indicated (diagnostic and/or therapeutic) tumor resection, or biopsy.
Design:
All attempts will be made to obtain specimens immediately adjacent to the areas of resection taken for "permanent sections" in order to optimize the likelihood that the tumor seen on permanent sections is representative of that taken for genetic analysis.
Once tumor specimens have been acquired, they will be immediately brought to a liquid nitrogen cell/tissue storage container, -70/-80 degrees C, or -20 degrees C freezer (in order of preference) for storage.
Following storage of the specimens, the NCI-based study specimen coordinator will be contacted for determination of when frozen specimens will be sent to the NCI for analysis.
10 ml of whole blood will be obtained for analysis of SNP Analogs.
Patients will be evaluated every 6 months at a minimum.
A total of 1000 patients will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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.
Primary outcome
To generate a large publicly accessible molecular and genetic data base with prospective corollary clinical data for 1000 gliomas
Time frame: Ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 8487049Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, et al. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. doi: 10.1200/JCO.1993.11.5.850.
- Background: PubMed 3382171Cairncross JG, Macdonald DR. Successful chemotherapy for recurrent malignant oligodendroglioma. Ann Neurol. 1988 Apr;23(4):360-4. doi: 10.1002/ana.410230408.
- Background: PubMed 7807189Fine HA. The basis for current treatment recommendations for malignant gliomas. J Neurooncol. 1994;20(2):111-20. doi: 10.1007/BF01052722.
Related trials for Glioma
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Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
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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.
Ronald E Gress, M.D. principal investigator
National Cancer Institute (NCI)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Glioblastoma Multiforme, run by National Cancer Institute (NCI) at 3 sites in United States.
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: stopped early, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early. Results are not available in the source record.
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?
To generate a large publicly accessible molecular and genetic data base with prospective corollary clinical data for 1000 gliomas (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00031538, which also lists 3 linked publications.
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 9 Dec 2019.