- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00592865
Risk Factors for Adult-Onset Brain Tumors
Genetic Epidemiology of Adult Brain Tumors
Study Objective:
Brain tumors are poorly understood. The purpose of this research is to examine whether factors in lifestyle play a role in brain tumor development. The study will also investigate the contribution of inherited susceptibility to the risk of brain cancer. By gaining a better understanding of these influences, the investigators hope to learn how to prevent brain tumors in future generations, and to develop more effective strategies for treatment.
Study Protocol:
This is a case-control investigation. Persons affected with a brain tumor are compared to unaffected persons on previous medical history, diet and other factors. Those enrolled in the study will participate in an interview on general background, diet, medical history and lifestyle, and will provide a sample of DNA, clippings of your toenails, and a tap water sample from your home. All procedures are performed in the clinic or through the mail.
'Cases': Cases eligible for the study are persons with a recent diagnosis of a primary brain tumor (glioma or meningioma), at least 18 years of age.
'Controls': Controls in the study are non-family members of patients, similar in age and of the same gender. Suitable controls include in-laws, friends, neighbors and co-workers.
Study Overview
Status
Detailed Description
Primary Objective:
The primary objective of this research is to establish a clinic-based case-control study for examination of potential risk factors for primary adult brain tumors. After assembling a series of 1,500 cases and 3,000 controls, investigators will test current hypotheses on ge-netic and environmental risk factors for the occurrence of these tumors.
STUDY DESIGN:
In this case-control study, persons with a recent diagnosis (within 4 months) of a primary brain tumor will be identified in the neurology/neurosurgery clinics at major treatment referral centers in the Southeast. Non-blood related relatives (eg. in-laws), friends or other persons will be recruited as controls. Names and contact information of eligible controls will be ascertained from patients. A total of 1,500 cases and 3,000 controls will be enrolled over the course of the 5-year study. All enrolled subjects will complete a one hour interview on lifestyle, environmental exposures, diet, physical activity, tobacco use and medical history. They will also be asked to provide a DNA sample, a water sample and a toenail sample (from each great toe). At the end of data collection, lifestyles and genetic attributes will be compared in cases and controls to identify any differences that may be relevant to the causation of disease. Because the study will recruit patients near the time of disease diagnosis, full enrollment should be possible. In addition, high re-sponse rates are anticipated among the controls. Thus, with the large numbers of patients available and high anticipated response rates, the study offers a unique opportunity to successfully identify environmental and genetic risk factors for this uncommon form of cancer.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Kentucky
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Louisville, Kentucky, United States, 40202
- Kentuckaina Cancer Institute
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center, Department of Neurological Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Case: Incident primary glioma or meningioma of any stage, diagnosed within 4 months.
- Control: non-blood relative, friend, co-worker of same gender as case
- Aged 18 and older; either gender; any race
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Burt Nabors, MD, University of Alabama at Birmingham
- Principal Investigator: Kathleen M. Egan, DSc, H. Lee Moffitt Cancer Center
- Principal Investigator: Reid C. Thompson, MD, Vanderbilt University Medical Center
- Principal Investigator: Renato V. LaRocca, MD, Kentuckiana Cancer Center
- Principal Investigator: Jeffrey Olson, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030917
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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