Gliogene: Brain Tumor Linkage Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00418899
First received: January 3, 2007
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Brain Tumor
Glioma
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Gliogene: Brain Tumor Linkage Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patients' Susceptibility Genes in High-risk Familial Brain Tumor Pedigrees [ Time Frame: 13 Years (Collection of blood tests and survey/interviews) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

About 3 tablespoons of blood will be drawn and if unable to donate blood, researchers will collect a saliva sample.


Estimated Enrollment: 17080
Study Start Date: February 2004
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
GLIOGENE
International Multi-Center, Multidisciplinary Study Consortium
Behavioral: Questionnaire
Questionnaire, 30-40 minutes, about gliomas and its risk factors (such as environmental and genetic information).
Other Name: Survey

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study participants with a glioma or a family member of someone with a glioma.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria: None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418899

Locations
United States, California
University of California Medical Center, San Francisco
San Francisco, California, United States, 94143
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
University of Illinois Medical Center, Chicago
Chicago, Illinois, United States, 60612
Evanston NW Healthcare
Evanston, Illinois, United States, 60201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Denmark
Institute of Cancer Epidemiology
Copenhagen, Denmark
Finland
Tampere University Hospital
Tampere, Finland
Israel
The Danek Gertner Institute
Tel Hashomer, Israel
Sweden
Umeå University Hospital
Umeå, Sweden
United Kingdom
Institute of Cancer Research
London, United Kingdom
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Chris Amos, PHD, MS, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00418899     History of Changes
Other Study ID Numbers: 2003-0974, 1R01CA119215-01A1
Study First Received: January 3, 2007
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Brain Tumor
Glioma
Linkage Study
Survey
Gliogene
High-risk familial brain tumor pedigrees

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 28, 2014