Brain TumorsNCT00339300
A Case-Referent Study of Brain Tumors in Adults
An observational study of Brain Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Brain Tumors
- How many people
- 1,581 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 1994to 26 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years.
- Subjects with malignant and benign adult brain tumors from hospitals in Boston, Phoenix and Pittsburgh.
- Patients admitted to the same hospitals as the cases, and treated for any of a variety of non-malignant conditions.
Who cannot join
- 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).
- Controls were excluded if cancer was responsible for the hospital admission.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Brain Tumors
- Keywords
- Etiology, Brain Cancer, Epidemiology, Brain Tumors, Glioma
- Medical subject headings
- Brain Neoplasms, Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Tumor
Measured: 07/15/1994
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start19 Aug 1994
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,581 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Cari M Kitahara, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339300
- Sponsor's protocol ID
- 999994036
- Other IDs
- OH94-C-N036
- Status last verified
- 26 Feb 2018
- First submitted
- 19 Jun 2006
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
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.
PubMed 11150357Brenner 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.
PubMed 11979441De 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.
PubMed 12749719
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Referent Study of Brain Tumors in Adults
- ClinicalTrials.gov ID
- NCT00339300
- Acronym / sponsor ID
- 999994036
- Conditions
- Brain Tumors
- Keywords
- Etiology, Brain Cancer, Epidemiology, Brain Tumors, Glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,581 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 19 Aug 1994
- Study completion
- 26 Feb 2018
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years.
- Subjects with malignant and benign adult brain tumors from hospitals in Boston, Phoenix and Pittsburgh.
- Patients admitted to the same hospitals as the cases, and treated for any of a variety of non-malignant conditions.
Key exclusion criteria (2 listed)
- 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).
- Controls were excluded if cancer was responsible for the hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain Tumor
Time frame: 07/15/1994
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 11150357Inskip 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.
- Background: PubMed 11979441Brenner 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.
- Background: PubMed 12749719De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cari M Kitahara principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Tumor (time frame: 07/15/1994). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339300, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.