Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00418899 |
| Other study ID # |
2003-0974 |
| Secondary ID |
1R01CA119215-01A |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 12, 2004 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
December 2020 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
