Lung DiseasesNCT00041860
Modulation of Benzene Metabolism by Exposure to Environment
A study of Lung Diseases and Cancer, run by National Institute of Environmental Health Sciences (NIEHS).
Trial summary
The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases, Cancer
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 Any age
- Child, Adult, Older adult
About this study
The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured.
Read the detailed description
The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured. The exposures take place in the Controlled Environmental Facility operated by the Environmental and Occupational Health Sciences Institute (EOHSI). This allows us to control the exact benzene air level and to use benzene containing 13C, a stable (non-radioactive) form of carbon, one of the atoms that make up benzene. Isotopes are different forms of the same atom. Using 13C will allow us to tell the difference between the benzene and the compounds it changes to in the body that come from our experiment compared to what is present in your body from other sources. In addition to just benzene exposure on some days the subject is also be exposed to methyl tertiary butyl ether (MTBE), another component of gasoline, to take an iron supplement pill and/or to take vitamins C and E pills. How benzene is metabolized or changed in the body will be compared for these differences to better understand how the body deals with benzene.
- Conditions
- Lung Diseases, Cancer
- Being tested
- Controlled Exposure to Environmental Contaminant
- Keywords
- Benzene, Air pollution
- Medical subject headings
- Lung Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Exposure to Environmental ContaminantProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041860
- Sponsor's protocol ID
- 9676-CP-001
- Status last verified
- Jul 2002
- First submitted
- 18 Jul 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Benzene Metabolism by Exposure to Environment
- ClinicalTrials.gov ID
- NCT00041860
- Acronym / sponsor ID
- 9676-CP-001
- Conditions
- Lung Diseases, Cancer
- Keywords
- Benzene, Air pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- First posted
- 22 Jul 2002 (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 research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured.
Detailed description
The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured. The exposures take place in the Controlled Environmental Facility operated by the Environmental and Occupational Health Sciences Institute (EOHSI). This allows us to control the exact benzene air level and to use benzene containing 13C, a stable (non-radioactive) form of carbon, one of the atoms that make up benzene. Isotopes are different forms of the same atom. Using 13C will allow us to tell the difference between the benzene and the compounds it changes to in the body that come from our experiment compared to what is present in your body from other sources. In addition to just benzene exposure on some days the subject is also be exposed to methyl tertiary butyl ether (MTBE), another component of gasoline, to take an iron supplement pill and/or to take vitamins C and E pills. How benzene is metabolized or changed in the body will be compared for these differences to better understand how the body deals with benzene.
Study design
Who may qualify
- Age groups
- Child, 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 |
|---|---|---|
| Controlled Exposure to Environmental Contaminant | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Lung Diseases and Cancer, run by National Institute of Environmental Health Sciences (NIEHS).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 24 Jun 2005.