Brain TumorNCT00418899
Gliogene: Brain Tumor Linkage Study
An observational study of Brain Tumor and Glioma, run by M.D. Anderson Cancer Center at 15 sites in 6 countries.
Trial summary
The goal of this research study is to investigate the role of genes that may point to a higher risk of developing a glioma. Researchers will use new gene mapping techniques to study how high-risk factors are passed on through a family's genes and increase the risk of developing gliomas. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor, Glioma
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17,080 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 12 Feb 2004to 1 Sep 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study participants with a glioma or a family member of someone with a glioma.
Who may be able to join
- 1) An affected or unaffected member of a family that has two or more reported gliomas (ICD9 codes 191.0-191.9) in the family.
Who cannot join
- N/A
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United States10 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Illinois Medical Center, Chicago
Chicago, Illinois, 60612
Evanston NW Healthcare
Evanston, Illinois, 60201
Baylor College of Medicine
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of California Medical Center, San Francisco
San Francisco, California, 94143
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
The goal of this research study is to investigate the role of genes that may point to a higher risk of developing a glioma. Researchers will use new gene mapping techniques to study how high-risk factors are passed on through a family's genes and increase the risk of developing gliomas.
Objectives:
Read more
We propose an international multi-center, multidisciplinary study consortium, GLIOGENE, to identify susceptibility genes in high-risk familial brain tumor pedigrees using the most sophisticated genetic analysis methods available. To address our hypothesis, we propose the following specific aims:
Aim 1: Establish a cohort of 400 high-risk pedigrees for genetic linkage analysis. To date, we have identified and collected biologic samples from 20 high-risk families that have met our criteria of 2 or more relatives diagnosed with a brain tumor. From the 15 centers in the United States and Europe, we will screen and obtain epidemiologic data from approximately 17,080 gliomas cases to identify a target of 400 families for genetic analysis. We will establish a cohort of the first and second-degree relatives from these glioma cases to obtain new knowledge about how cancer aggregates in glioma families. We will also acquire biospecimens (blood and tumor tissue), and risk factor data from relevant family members.
Aim 2: Identify candidate regions linked to familial brain tumors. To strengthen evidence of linkage to regions found in our preliminary analysis and to identify additional regions linked to brain tumors, we will genotype informative glioma pedigrees identified in aim 1 using Affymetrix 10K GeneChip with markers spaced throughout the genome, and conduct a genome-wide multipoint linkage scan with these markers.
Aim 3: Fine map the regions established in Aim 2 by genotyping selected SNPs from genome databases. We will attempt to further refine the regions identified in Aim 2 to less than 1cM by using approximately 1,500 - 2,000 carefully selected SNPs. The prioritization of regions will be based on a combination of the strength of evidence for linkage from families of various ethnic backgrounds and the presence of obvious candidate genes.
Read the detailed description
A consortium (group) of researchers wants to learn more about gliomas as well as the risk factors (such as environmental and genetic information) for patients with this kind of brain tumor. Participants in this study will be part of a glioma genetic epidemiology study (herein referred to as "GLIOGENE") involving eleven centers in the United States (U.S.) and five centers in Europe. The eleven centers in the U.S. are: The University of Texas MD Anderson Cancer Center (MD Anderson); Baylor College of Medicine, Texas Children's Hospital (TCH); Brigham and Women's Hospital (BWH); Case Western Reserve University (CWRU); Columbia University Medical Center (CUMD); Duke University (Duke); Mayo Clinic Rochester (Mayo); Memorial Sloan-Kettering Cancer Center (MSKCC); University of California, San Francisco (UCSF); University of Illinois, Chicago (UIC); and Evanston Northwest Healthcare (ENWH). The five centers in Europe are: Gertner Institute, Israel (Gertner); Institute of Cancer Epidemiology, Denmark (ICE); Institute of Cancer Research (ICR), United Kingdom (U.K.); Tampere University Hospital (TU) and Umeå University Hospital, Sweden (Umeå).
If you agree to take part in this study, you will have about 3 tablespoons of blood drawn. If you are unable to donate blood, researchers will collect a saliva sample.
In addition, if you have 2 or more family members with a glioma, a trained research interviewer will ask you questions using a questionnaire that will take about 30-40 minutes to complete. The topics in the questionnaire will include demographic data (such as age and race), environmental exposures, medical history, family history of cancer and other conditions, and other lifestyle factors.
Study staff will only use any names and contact information of relatives or other potential research participants provided to MD Anderson in order to contact those individuals to find out if they are eligible and desire to participate in this study.
Before your blood and/or saliva is sent to TCH for banking, your name and any personal identifying information will be coded to protect your privacy. MD Anderson will not have oversight of any leftover blood and/or saliva that will be banked by THC for additional research. Blood and saliva that are collected will only be used by researchers involved in this study.
Neither you nor your physicians will receive individual reports of this research. Results will not be placed in your health records. All information will be kept confidential and used only for research purposes. For the results, your sample, contact and medical information will be linked by assigning an identification number (instead of your name).
In the event that any participant has participated in prior glioma studies conducted by Melissa L. Bondy (ID00-098 or ID 91-036), signing the informed consent for this study will allow us to use their specimens previously collected.
There is a rare chance that a research team member could be accidentally exposed to your blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be used for these tests instead. You will be told that your blood is being tested and the results of your test. Researchers will ask how you would like to receive the results, such as by phone or certified letter. The test results and your name, address, date of birth, and sex will be recorded in the confidential MD Anderson medical records.
If you test positive for hepatitis or HIV, the test results and your name, address, date of birth, and sex will be shared with appropriate health authorities as required by law. You will also be given a list of places in your area so that you can receive further testing and treatment.
Your participation will be over in this study after the data has been collected and finalized.
This is an investigational study. Up to 17,080 participants will take part in this multicenter study. Up to 9,000 will be enrolled at M.D. Anderson.
- Conditions
- Brain Tumor, Glioma
- Being tested
- Questionnaire
- Keywords
- Brain Tumor, Glioma, Linkage Study, Survey, Gliogene, High-risk familial brain tumor pedigrees
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire, 30-40 minutes, about gliomas and its risk factors (such as environmental and genetic information).
| Study group | Role | What they receive |
|---|---|---|
| GLIOGENE | International Multi-Center, Multidisciplinary Study Consortium Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Susceptibility Genes in High-risk Familial Brain Tumor Pedigrees
Measured: 13 Years (Collection of blood tests and survey/interviews)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study start12 Feb 2004
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 17,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sanjay Shete, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418899
- Sponsor's protocol ID
- 2003-0974
- Other IDs
- 1R01CA119215-01A1
- Status last verified
- Dec 2020
- First submitted
- 3 Jan 2007
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gliogene: Brain Tumor Linkage Study
- ClinicalTrials.gov ID
- NCT00418899
- Acronym / sponsor ID
- 2003-0974
- Conditions
- Brain Tumor, Glioma
- Keywords
- Brain Tumor, Glioma, Linkage Study, Survey, Gliogene, High-risk familial brain tumor pedigrees
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17,080 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Feb 2004 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 5 Jan 2007 (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.
The goal of this research study is to investigate the role of genes that may point to a higher risk of developing a glioma. Researchers will use new gene mapping techniques to study how high-risk factors are passed on through a family's genes and increase the risk of developing gliomas.
Objectives:
We propose an international multi-center, multidisciplinary study consortium, GLIOGENE, to identify susceptibility genes in high-risk familial brain tumor pedigrees using the most sophisticated genetic analysis methods available. To address our hypothesis, we propose the following specific aims:
Aim 1: Establish a cohort of 400 high-risk pedigrees for genetic linkage analysis. To date, we have identified and collected biologic samples from 20 high-risk families that have met our criteria of 2 or more relatives diagnosed with a brain tumor. From the 15 centers in the United States and Europe, we will screen and obtain epidemiologic data from approximately 17,080 gliomas cases to identify a target of 400 families for genetic analysis. We will establish a cohort of the first and second-degree relatives from these glioma cases to obtain new knowledge about how cancer aggregates in glioma families. We will also acquire biospecimens (blood and tumor tissue), and risk factor data from relevant family members.
Aim 2: Identify candidate regions linked to familial brain tumors. To strengthen evidence of linkage to regions found in our preliminary analysis and to identify additional regions linked to brain tumors, we will genotype informative glioma pedigrees identified in aim 1 using Affymetrix 10K GeneChip with markers spaced throughout the genome, and conduct a genome-wide multipoint linkage scan with these markers.
Aim 3: Fine map the regions established in Aim 2 by genotyping selected SNPs from genome databases. We will attempt to further refine the regions identified in Aim 2 to less than 1cM by using approximately 1,500 - 2,000 carefully selected SNPs. The prioritization of regions will be based on a combination of the strength of evidence for linkage from families of various ethnic backgrounds and the presence of obvious candidate genes.
Detailed description
A consortium (group) of researchers wants to learn more about gliomas as well as the risk factors (such as environmental and genetic information) for patients with this kind of brain tumor. Participants in this study will be part of a glioma genetic epidemiology study (herein referred to as "GLIOGENE") involving eleven centers in the United States (U.S.) and five centers in Europe. The eleven centers in the U.S. are: The University of Texas MD Anderson Cancer Center (MD Anderson); Baylor College of Medicine, Texas Children's Hospital (TCH); Brigham and Women's Hospital (BWH); Case Western Reserve University (CWRU); Columbia University Medical Center (CUMD); Duke University (Duke); Mayo Clinic Rochester (Mayo); Memorial Sloan-Kettering Cancer Center (MSKCC); University of California, San Francisco (UCSF); University of Illinois, Chicago (UIC); and Evanston Northwest Healthcare (ENWH). The five centers in Europe are: Gertner Institute, Israel (Gertner); Institute of Cancer Epidemiology, Denmark (ICE); Institute of Cancer Research (ICR), United Kingdom (U.K.); Tampere University Hospital (TU) and Umeå University Hospital, Sweden (Umeå).
If you agree to take part in this study, you will have about 3 tablespoons of blood drawn. If you are unable to donate blood, researchers will collect a saliva sample.
In addition, if you have 2 or more family members with a glioma, a trained research interviewer will ask you questions using a questionnaire that will take about 30-40 minutes to complete. The topics in the questionnaire will include demographic data (such as age and race), environmental exposures, medical history, family history of cancer and other conditions, and other lifestyle factors.
Study staff will only use any names and contact information of relatives or other potential research participants provided to MD Anderson in order to contact those individuals to find out if they are eligible and desire to participate in this study.
Before your blood and/or saliva is sent to TCH for banking, your name and any personal identifying information will be coded to protect your privacy. MD Anderson will not have oversight of any leftover blood and/or saliva that will be banked by THC for additional research. Blood and saliva that are collected will only be used by researchers involved in this study.
Neither you nor your physicians will receive individual reports of this research. Results will not be placed in your health records. All information will be kept confidential and used only for research purposes. For the results, your sample, contact and medical information will be linked by assigning an identification number (instead of your name).
In the event that any participant has participated in prior glioma studies conducted by Melissa L. Bondy (ID00-098 or ID 91-036), signing the informed consent for this study will allow us to use their specimens previously collected.
There is a rare chance that a research team member could be accidentally exposed to your blood or body fluids. If that occurs, extra blood (about 2 teaspoons) may be drawn to test for infections such as hepatitis and HIV (the AIDS virus). An existing blood sample may be used for these tests instead. You will be told that your blood is being tested and the results of your test. Researchers will ask how you would like to receive the results, such as by phone or certified letter. The test results and your name, address, date of birth, and sex will be recorded in the confidential MD Anderson medical records.
If you test positive for hepatitis or HIV, the test results and your name, address, date of birth, and sex will be shared with appropriate health authorities as required by law. You will also be given a list of places in your area so that you can receive further testing and treatment.
Your participation will be over in this study after the data has been collected and finalized.
This is an investigational study. Up to 17,080 participants will take part in this multicenter study. Up to 9,000 will be enrolled at M.D. Anderson.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLIOGENE | – | Behavioral: QuestionnaireInternational Multi-Center, Multidisciplinary Study Consortium |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants with a glioma or a family member of someone with a glioma.
Key inclusion criteria (1 listed)
- 1) An affected or unaffected member of a family that has two or more reported gliomas (ICD9 codes 191.0-191.9) in the family.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire, 30-40 minutes, about gliomas and its risk factors (such as environmental and genetic information). | Behavioural | GLIOGENE |
Primary outcome
Patients' Susceptibility Genes in High-risk Familial Brain Tumor Pedigrees
Time frame: 13 Years (Collection of blood tests and survey/interviews)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Sanjay Shete, PHD principal investigator
M.D. Anderson Cancer Center
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Glioma, run by M.D. Anderson Cancer Center at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Denmark, Finland, Israel, Sweden and 1 more country. 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?
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?
Patients' Susceptibility Genes in High-risk Familial Brain Tumor Pedigrees (time frame: 13 Years (Collection of blood tests and survey/interviews)). 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 31 Dec 2020.