Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418899
Status:
UNKNOWN
Last Update Posted:
2020-12-31
First Post:
2007-01-03
Brief Title:
Gliogene Brain Tumor Linkage Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Gliogene Brain Tumor Linkage Study
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 familys 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 17080 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 1500 - 2000 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
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 17080 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 1500 - 2000 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 US and five centers in Europe The eleven centers in the US are The University of Texas MD Anderson Cancer Center MD Anderson Baylor College of Medicine Texas Childrens Hospital TCH Brigham and Womens 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 UK 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 andor 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 andor 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 17080 participants will take part in this multicenter study Up to 9000 will be enrolled at MD Anderson
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 andor 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 andor 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 17080 participants will take part in this multicenter study Up to 9000 will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA119215-01A1 | NIH | None | httpsreporternihgovquickSearch1R01CA119215-01A1 |