Risk Factors for Adult-Onset Brain Tumors

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ClinicalTrials.gov Identifier: NCT00592865

Recruitment Status : Terminated

First Posted : January 14, 2008

Last Update Posted : April 4, 2017

Sponsor:

Collaborators:

H. Lee Moffitt Cancer Center and Research Institute

Kentuckiana Cancer Institute

Emory University

University of Alabama at Birmingham

Information provided by (Responsible Party):

Reid Thompson, Vanderbilt University Medical Center

Study Description

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.

Condition or disease
Brain Neoplasm, Primary Brain Neoplasms, Malignant Brain Neoplasms, Benign

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 Design


Study Type :	Observational
Actual Enrollment :	850 participants
Observational Model:	Other
Time Perspective:	Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Genetic and Rare Diseases Information Center resources: Brain Tumor, Adult

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention: Samples With DNA

Mouthwash and salvia samples. Toenail samples are also collected.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

"Case" subjects will be identified from the patients referred to neurology/neurosurgery clinics. Cases, when enrolled in the study, will be asked to identify potential "controls" by providing the name and phone number of the same-sex in-law nearest in age to the case and/or the name of a same-sex friend will also be sought.

Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

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

Locations


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
Emory University
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

Sponsors and Collaborators

Vanderbilt University

H. Lee Moffitt Cancer Center and Research Institute

Kentuckiana Cancer Institute

Emory University

University of Alabama at Birmingham

Investigators


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

More Information


Responsible Party:	Reid Thompson, Department Chair and Professor, Neurological Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00592865 History of Changes
Other Study ID Numbers:	030917
First Posted:	January 14, 2008 Key Record Dates
Last Update Posted:	April 4, 2017
Last Verified:	March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms	Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases

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