Clinical trial NCT00592865: Risk Factors for Adult-Onset Brain Tumors
Official title: Genetic Epidemiology of Adult Brain Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Neoplasm, Primary
Brain Neoplasms, Malignant
Brain Neoplasms, Benign
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
name: Kentuckiana Cancer Institute
name: Emory University
name: University of Alabama at Birmingham
First posted: 2008-01-14
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

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 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:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Louisville
country: United States
facility: Kentuckaina Cancer Institute
state: Kentucky
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Department of Neurological Surgery
state: Tennessee
Study officials:
affiliation: H. Lee Moffitt Cancer Center
name: Kathleen M. Egan, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Reid C. Thompson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kentuckiana Cancer Center
name: Renato V. LaRocca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Jeffrey Olson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Burt Nabors, MD
role: PRINCIPAL_INVESTIGATOR
References: