Clinical trial NCT00339300: A Case-Referent Study of Brain Tumors in Adults
Official title: A Case-Referent Study of Brain Tumors in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumors
Keywords: Etiology
Brain Cancer
Epidemiology
Brain Tumors
Glioma
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: Centers for Disease Control and Prevention
name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2006-06-21
Enrollment: 1581
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Brain Tumor
timeFrame: 07/15/1994
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: National Cancer Institute (NCI)
name: Cari M Kitahara
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1056/NEJM200101113440201.
citation: 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. doi: 10.1002/ijc.10320.
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. doi: 10.1023/a:1023053916689.