NCT00418899

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 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2004

Longer than P75 for all trials

Geographic Reach
6 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
15.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

18.6 years

First QC Date

January 3, 2007

Last Update Submit

December 29, 2020

Conditions

Keywords

Brain TumorGliomaLinkage StudySurveyGliogeneHigh-risk familial brain tumor pedigrees

Outcome Measures

Primary Outcomes (1)

  • Patients' Susceptibility Genes in High-risk Familial Brain Tumor Pedigrees

    13 Years (Collection of blood tests and survey/interviews)

Study Arms (1)

GLIOGENE

International Multi-Center, Multidisciplinary Study Consortium

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaire, 30-40 minutes, about gliomas and its risk factors (such as environmental and genetic information).

Also known as: Survey
GLIOGENE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \) An affected or unaffected member of a family that has two or more reported gliomas (ICD9 codes 191.0-191.9) in the family.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of California Medical Center, San Francisco

San Francisco, California, 94143, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Illinois Medical Center, Chicago

Chicago, Illinois, 60612, United States

Location

Evanston NW Healthcare

Evanston, Illinois, 60201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Institute of Cancer Epidemiology

Copenhagen, Denmark

Location

Tampere University Hospital

Tampere, Finland

Location

The Danek Gertner Institute

Tel Litwinsky, Israel

Location

Umeå University Hospital

Umeå, Sweden

Location

Institute of Cancer Research

London, United Kingdom

Location

Related Links

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.

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sanjay Shete, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 5, 2007

Study Start

February 12, 2004

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations