Risk Factors for Adult-Onset Brain Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00592865|
Recruitment Status : Terminated
First Posted : January 14, 2008
Last Update Posted : April 4, 2017
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.
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.
|Condition or disease|
|Brain Neoplasm, Primary Brain Neoplasms, Malignant Brain Neoplasms, Benign|
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.
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 :||Observational|
|Actual Enrollment :||850 participants|
|Official Title:||Genetic Epidemiology of Adult Brain Tumors|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592865
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|H. Lee Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Kentucky|
|Kentuckaina Cancer Institute|
|Louisville, Kentucky, United States, 40202|
|United States, Tennessee|
|Vanderbilt University Medical Center, Department of Neurological Surgery|
|Nashville, Tennessee, United States, 37232|
|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|
|Principal Investigator:||Burt Nabors, MD||University of Alabama at Birmingham|