Full Text View
Tabular View
No Study Results Posted
Related Studies
A Case-Referent Study of Brain Tumors in Adults
This study has been completed.
First Received: June 19, 2006   Last Updated: September 12, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Collaborator: Centers for Disease Control and Prevention
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00339300
  Purpose

The etiology of brain tumors is poorly understood. Due, in part, to public concern about a postulated relationship between the use of cellular telephones or other increasingly prevalent environmental exposures and the incidence of brain cancer in adults, the National Cancer Institute is collaborating with three U.S. hospitals in a comprehensive case-control study of malignant and benign brain tumors. Factors under consideration include use of cellular phones and other wireless communication devices, workplace exposures to chemical agents and electromagnetic fields, dietary factors, family history of tumors, genetic determinants of susceptibility, home appliance use, reproductive history and hormonal exposures, viruses, medical and dental exposure to ionizing radiation, and other aspects of medical history.

Approximately 800 newly diagnosed brain tumor cases and 800 controls have been enrolled at hospitals in Boston, Phoenix and Pittsburgh. Cases include all adults (age greater than or equal to 18 years) newly diagnosed with a histologically confirmed intracranial glioma, intracranial meningioma or acoustic neuroma. Controls are patients admitted to the same hospitals as the cases, and treated for any of a variety of non-malignant conditions. Participating cases and controls were interviewed in the hospital by a research nurse and asked to complete a self-administered questionnaire and donate a sample of blood. Key features of the study include its large size, the emphasis on rapid ascertainment of incident cases and interview of study subjects rather than surrogate respondents, the use of detailed, job-specific questions developed by industrial hygienists to ascertain occupational exposures, and the storage of blood samples for future evaluation of inherited susceptibility, biomarkers of exposure and gene-environment interactions.

Implementation of the study protocol proceeded without serious problems. There have been no harmful effects on study participants. There have been no complaints from participants or breaches of confidentiality. Continuation of this research involves analysis and reporting of results. As there will be many papers, this process is expected to extend over the next several years.


Condition
Brain Tumors

Study Type: Observational
Official Title: A Case-Referent Study of Brain Tumors in Adults

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1600
Study Start Date: August 1994
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The etiology of brain cancer is largely unknown, although several chemicals and occupations have been associated with the disease. Occupations in the agricultural industry have shown associations with brain cancer in several studies, and pesticides and fertilizers have been suggested as the etiologic agent. This case-control study will accrue 798 cases and 1175 controls form four Midwestern states to investigate this hypothesis. This study was initiated and completed by the National Institute for Occupational Safety and Health (NIOSH), an agency of the CDC. Investigators at NCI have since been asked to join the study to allow merging of the NCI brain cancer study data with the NIOSH study data to provide more power in the analyses.

Cases will be identified from hospitals and neurosurgeon offices in these states. Controls will be frequency matched and obtained from state driver's license records and HCFA Medicare records. A questionnaire will be administered to collect information on occupational exposures, residential history, and other variables. Water samples will be collected from subjects with private wells. Tissue will be collected from the cases and blood from both cases and controls. An industrial hygienist will identify possible chemical agents and estimate levels to those agents based on the literature and her experience. Levels of disinfection by-products in municipal and private wells will be estimated from state records. The biologic tissues will be evaluated for markers for exposure, mutation, DNA repair, or metabolic polymorphisms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Age greater than or equal to 18 years.

Subjects with malignant and benign adult brain tumors from hospitals in Boston, Phoenix and Pittsburgh.

INCLUSION CRITERIA - Controls:

Patients admitted to the same hospitals as the cases, and treated for any of a variety of non-malignant conditions.

EXCLUSION CRITERIA:

Reasons for exclusion of cases included absense of histologic confirmation or ineligible diagnosis (e.g., schwannoma of facial or trigeminal nerve rather than of acoustic nerve).

EXCLUSION CRITERIA - Controls:

Controls were excluded if cancer was responsible for the hospital admission.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00339300

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 999994036, OH94-C-N036
Study First Received: June 19, 2006
Last Updated: September 12, 2009
ClinicalTrials.gov Identifier: NCT00339300     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Case-Control
Etiology
Environmental Factors
Occupation
Familial
Genetic
Boston
Pittsburgh
Phoenix

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

ClinicalTrials.gov processed this record on November 30, 2009