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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | January 7, 2008 | ||||||||||||||||||||
| Last Updated Date | January 11, 2008 | ||||||||||||||||||||
| Start Date ICMJE | October 2003 | ||||||||||||||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00592865 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Risk Factors for Adult-Onset Brain Tumors | ||||||||||||||||||||
| Official Title ICMJE | Genetic Epidemiology of Adult Brain Tumors | ||||||||||||||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Other, Other | ||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||
| Publications * | |||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 750 | ||||||||||||||||||||
| Estimated Completion Date | July 2012 | ||||||||||||||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00592865 | ||||||||||||||||||||
| Responsible Party | Kathleen Egan, DSC, Moffitt Cancer Center | ||||||||||||||||||||
| Study ID Numbers ICMJE | 030917 | ||||||||||||||||||||
| Study Sponsor ICMJE | Vanderbilt University | ||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||||||||||||||||||
| Verification Date | January 2008 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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