Risk Factors for Adult-Onset Brain Tumors

Brain Neoplasms, Malignant Clinical Trial

Official title:

Genetic Epidemiology of Adult Brain Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00592865
• Other study ID #: 030917
• Status: Terminated
• Start date: October 2003
• Est. completion date: January 2015

Study information

• Verified date: February 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 850
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Kentuckaina Cancer Institute	Louisville	Kentucky
United States	Vanderbilt University Medical Center, Department of Neurological Surgery	Nashville	Tennessee
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Emory University, H. Lee Moffitt Cancer Center and Research Institute, Kentuckiana Cancer Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

United States,