A Case-Referent Study of Brain Tumors in Adults

Brain Tumors Clinical Trial

Official title:

A Case-Referent Study of Brain Tumors in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339300
• Other study ID #: 999994036
• Secondary ID: OH94-C-N036
• Status: Completed
• First received: June 19, 2006
• Last updated: April 4, 2018
• Start date: August 19, 1994
• Est. completion date: February 26, 2018

Study information

• Verified date: February 26, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 US hospitals in a comprehensive case-control study of malignant and benign brain tumors. Factors under consideration include the 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 exposures 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 age greater than or equal to 18 years) newly diagnosed with a histologically confirmed intracranial giloma, 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 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. Numerous publications have resulted from the study and analyses are ongoing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1581
• Est. completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brenner AV, Linet MS, Fine HA, Shapiro WR, Selker RG, Black PM, Inskip PD. History of allergies and autoimmune diseases and risk of brain tumors in adults. Int J Cancer. 2002 May 10;99(2):252-9. — View Citation

De Roos AJ, Stewart PA, Linet MS, Heineman EF, Dosemeci M, Wilcosky T, Shapiro WR, Selker RG, Fine HA, Black PM, Inskip PD. Occupation and the risk of adult glioma in the United States. Cancer Causes Control. 2003 Mar;14(2):139-50. — View Citation

Inskip PD, Tarone RE, Hatch EE, Wilcosky TC, Shapiro WR, Selker RG, Fine HA, Black PM, Loeffler JS, Linet MS. Cellular-telephone use and brain tumors. N Engl J Med. 2001 Jan 11;344(2):79-86. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Tumor		07/15/1994