Brain and Central Nervous System TumorsNCT00340054
Developing Interview Questions to Estimate Workplace Exposure to Electric and Magnetic Fields
An observational study of Brain and Central Nervous System Tumors, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
RATIONALE: Electric and magnetic fields may increase the risk of cancer. Developing interview questions that accurately estimate a person's exposure to electric and magnetic fields may help doctors learn about the long-term effects of workplace exposure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- questionnaire administration and study of high risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Mar 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following occupation criteria:
- Three occupations that primarily work in offices at Lawrence Livermore National Laboratories (LLNL)
- Three occupations that do nonelectric manual work (e.g., machinists and laborers) at LLNL
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute for Occupational Safety and Health
Cincinnati, Ohio, 45226
Exponent, Inc.
Menlo Park, California, 94025
About this study
Official title: Assessment of Occupational EMF Exposure - Validation of Interview Procedures Used in Brain Tumor Study
RATIONALE: Electric and magnetic fields may increase the risk of cancer. Developing interview questions that accurately estimate a person's exposure to electric and magnetic fields may help doctors learn about the long-term effects of workplace exposure.
PURPOSE: This clinical trial is developing interview questions that can be used in estimating workplace exposure to electric and magnetic fields.
Read the detailed description
OBJECTIVES:
- Validate an interview-based electric and magnetic field exposure (EMF) assessment algorithm against measurements of the time-weighted average magnetic field magnitude used in previous epidemiologic studies.
- Calibrate the parameters in the algorithm in order to improve the exposure estimates.
- Correlate EMF exposure estimates from the algorithm with biologically based metrics measured by new instrumentation.
OUTLINE: Participants respond to questions during a 5- to 15-minute telephone interview concerning workplace exposure to electric and magnetic (EMF) fields. Data is collected during the interview using an exposure assessment algorithm designed to estimate EMF workplace exposure based on participants' responses. The interview-based estimates are then validated against actual field measurements of magnetic field exposure captured by Emdex multiwave monitors located at participating sites.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- questionnaire administration, study of high risk factors
- Keywords
- brain tumor
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of an interview-based electric and magnetic field (EMF) exposure assessment algorithm
Calibration of algorithm parameters
Correlation between EMF exposure estimates from the algorithm with biologically based metrics measured by new instrumentation
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 startOct 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- 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
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Joseph Coble, DSc, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340054
- Sponsor's protocol ID
- 99906013
- Other IDs
- 06-C-N013, 999906013, CDR0000551595
- Status last verified
- Mar 2012
- First submitted
- 19 Jun 2006
- Last updated
- 8 Mar 2012
- Results posted
- No
Publications
Kelsh MA, Kheifets L, Smith R. The impact of work environment, utility, and sampling design on occupational magnetic field exposure summaries. AIHAJ. 2000 Mar-Apr;61(2):174-82. doi: 10.1080/15298660008984526.
PubMed 10782189
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Occupational EMF Exposure - Validation of Interview Procedures Used in Brain Tumor Study
- ClinicalTrials.gov ID
- NCT00340054
- Acronym / sponsor ID
- 99906013
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- brain tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Study completion
- Mar 2007 (actual)
- 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.
RATIONALE: Electric and magnetic fields may increase the risk of cancer. Developing interview questions that accurately estimate a person's exposure to electric and magnetic fields may help doctors learn about the long-term effects of workplace exposure.
PURPOSE: This clinical trial is developing interview questions that can be used in estimating workplace exposure to electric and magnetic fields.
Detailed description
OBJECTIVES:
- Validate an interview-based electric and magnetic field exposure (EMF) assessment algorithm against measurements of the time-weighted average magnetic field magnitude used in previous epidemiologic studies.
- Calibrate the parameters in the algorithm in order to improve the exposure estimates.
- Correlate EMF exposure estimates from the algorithm with biologically based metrics measured by new instrumentation.
OUTLINE: Participants respond to questions during a 5- to 15-minute telephone interview concerning workplace exposure to electric and magnetic (EMF) fields. Data is collected during the interview using an exposure assessment algorithm designed to estimate EMF workplace exposure based on participants' responses. The interview-based estimates are then validated against actual field measurements of magnetic field exposure captured by Emdex multiwave monitors located at participating sites.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administration | Other | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Validation of an interview-based electric and magnetic field (EMF) exposure assessment algorithm
Calibration of algorithm parameters
Correlation between EMF exposure estimates from the algorithm with biologically based metrics measured by new instrumentation
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 8 Mar 2012.
- Background: PubMed 10782189Kelsh MA, Kheifets L, Smith R. The impact of work environment, utility, and sampling design on occupational magnetic field exposure summaries. AIHAJ. 2000 Mar-Apr;61(2):174-82. doi: 10.1080/15298660008984526.
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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.
Joseph Coble, DSc study chair
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors, run by National Institutes of Health Clinical Center (CC) at 2 sites 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?
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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Validation of an interview-based electric and magnetic field (EMF) exposure assessment algorithm. The study lists 3 primary outcomes in all. 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 NCT00340054, which also lists 1 linked publication.
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 8 Mar 2012; AzTrials last refreshed its copy on 31 Oct 2026.