Risk Factors for Adult-Onset Brain Tumors

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
H. Lee Moffitt Cancer Center and Research Institute
Kentuckiana Cancer Institute
Emory University
University of Alabama at Birmingham
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00592865
First received: January 7, 2008
Last updated: January 11, 2008
Last verified: January 2008
  Purpose

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
Brain Neoplasm, Primary
Brain Neoplasms, Malignant
Brain Neoplasms, Benign

Study Type: Observational
Official Title: Genetic Epidemiology of Adult Brain Tumors

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Biospecimen Retention:   Samples With DNA

Mouthwash and salvia samples. Toenail samples are also collected.


Estimated Enrollment: 750
Study Start Date: October 2003
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: Kathleen Egan, DSC, Moffitt Cancer Center
ClinicalTrials.gov Identifier: NCT00592865     History of Changes
Other Study ID Numbers: 030917
Study First Received: January 7, 2008
Last Updated: January 11, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014