Lung DiseaseNCT00014963
Biomarkers of Benzene Exposure in Inner City Residents
An observational study of Lung Disease and Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
This study compares air pollution exposures of residents in a South Baltimore community next to major industry with those in a comparison community with much less industry nearby. Parents and children as well as adults alone will be included. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Disease, Cancer
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
residence in one of the study communities
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Hygiene and Public Health
Baltimore, Maryland, 21205
About this study
This study compares air pollution exposures of residents in a South Baltimore community next to major industry with those in a comparison community with much less industry nearby. Parents and children as well as adults alone will be included. Air levels of 3 chemicals that have been found in increased amounts in the community as well as two urinary breakdown products of benzene will be measured. Participants will limit the amount of sorbate preserved foods they eat as this preservative interferes with one of the benzene breakdown products. Benzene air and urine exposure measurements will be compared in each community as well as between communities. By including children and parents we will gather exposure information on children who may be more sensitive that adults to these types of pollution. Lastly, by restricting the amount of food preserved with sorbates, we can decide if this improves the use of ttMA for people exposed to benzene from air pollution.
Read the detailed description
The current study focuses on an environmental exposure assessment of a South Baltimore community residing near a heavily industrialized area. Exposure differences between this community and a reference community that is demographically similar to South Baltimore but has limited industrial impact will be assessed. Participants will include both parent child study pairs and adults. Outdoor, indoor and personal 72 hour badge monitoring for benzene, 1,3-butadiene and carbon tetrachloride will be performed. Two urinary biomarkers for benzene exposure, trans,trans-muconic acid (ttMA) and s-phenylmercapturic acid (S-PMA) will be measured at 3 daily time points over the 3 day period. Past work indicates that ingestion of sorbate preserved foods causes substantial interference with the benzene biomarker, ttMA. Therefore, participants will restrict their intake of sorbate preserved foods during the study. On the day of greatest dietary restriction, a 24 hour benzene personal air measurement will be obtained. Data analysis will include correlations of benzene badge exposure measurements and urinary biomarkers. Air and biomarker benzene exposure data will be compared between communities. Linear regression modeling will be used to determine important explanatory factors of the biomarkers. The inclusion of parent child study pairs will also allow correlation of benzene air levels and urinary biomarkers between parents and children. This will provide exposure information on a potentially susceptible subpopulation, e.g. children, and allow assessment of potential for age-related differences in benzene metabolism. Finally, we will be able to determine if dietary restriction is practical and results in greater specificity of ttMA as a benzene biomarker.
- Conditions
- Lung Disease, Cancer
- Keywords
- benzene, biomarkers, air pollution, muconic acid, phenylmercapturic acid
- Medical subject headings
- Lung Diseases, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2001 (estimated)
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 Lung DiseaseStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Mickey Leland National Urban Air Toxics Research Center, Environmental Protection Agency (EPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014963
- Sponsor's protocol ID
- 7780-CP-001
- Status last verified
- Mar 2006
- First submitted
- 16 Apr 2001
- Last updated
- 23 Mar 2006
- Results posted
- No
Publications
Weaver VM, Buckley TJ, Groopman JD. Approaches to environmental exposure assessment in children. Environ Health Perspect. 1998 Jun;106 Suppl 3(Suppl 3):827-32. doi: 10.1289/ehp.98106827.
PubMed 9646045Weaver VM, Davoli CT, Heller PJ, Fitzwilliam A, Peters HL, Sunyer J, Murphy SE, Goldstein GW, Groopman JD. Benzene exposure, assessed by urinary trans,trans-muconic acid, in urban children with elevated blood lead levels. Environ Health Perspect. 1996 Mar;104(3):318-23. doi: 10.1289/ehp.96104318.
PubMed 8919771Weaver VM, Buckley T, Groopman JD. Lack of specificity of trans,trans-muconic acid as a benzene biomarker after ingestion of sorbic acid-preserved foods. Cancer Epidemiol Biomarkers Prev. 2000 Jul;9(7):749-55.
PubMed 10919747
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Benzene Exposure in Inner City Residents
- ClinicalTrials.gov ID
- NCT00014963
- Acronym / sponsor ID
- 7780-CP-001
- Conditions
- Lung Disease, Cancer
- Keywords
- benzene, biomarkers, air pollution, muconic acid, phenylmercapturic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Collaborators
- Mickey Leland National Urban Air Toxics Research Center, Environmental Protection Agency (EPA)
- First posted
- 18 Apr 2001 (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.
This study compares air pollution exposures of residents in a South Baltimore community next to major industry with those in a comparison community with much less industry nearby. Parents and children as well as adults alone will be included. Air levels of 3 chemicals that have been found in increased amounts in the community as well as two urinary breakdown products of benzene will be measured. Participants will limit the amount of sorbate preserved foods they eat as this preservative interferes with one of the benzene breakdown products. Benzene air and urine exposure measurements will be compared in each community as well as between communities. By including children and parents we will gather exposure information on children who may be more sensitive that adults to these types of pollution. Lastly, by restricting the amount of food preserved with sorbates, we can decide if this improves the use of ttMA for people exposed to benzene from air pollution.
Detailed description
The current study focuses on an environmental exposure assessment of a South Baltimore community residing near a heavily industrialized area. Exposure differences between this community and a reference community that is demographically similar to South Baltimore but has limited industrial impact will be assessed. Participants will include both parent child study pairs and adults. Outdoor, indoor and personal 72 hour badge monitoring for benzene, 1,3-butadiene and carbon tetrachloride will be performed. Two urinary biomarkers for benzene exposure, trans,trans-muconic acid (ttMA) and s-phenylmercapturic acid (S-PMA) will be measured at 3 daily time points over the 3 day period. Past work indicates that ingestion of sorbate preserved foods causes substantial interference with the benzene biomarker, ttMA. Therefore, participants will restrict their intake of sorbate preserved foods during the study. On the day of greatest dietary restriction, a 24 hour benzene personal air measurement will be obtained. Data analysis will include correlations of benzene badge exposure measurements and urinary biomarkers. Air and biomarker benzene exposure data will be compared between communities. Linear regression modeling will be used to determine important explanatory factors of the biomarkers. The inclusion of parent child study pairs will also allow correlation of benzene air levels and urinary biomarkers between parents and children. This will provide exposure information on a potentially susceptible subpopulation, e.g. children, and allow assessment of potential for age-related differences in benzene metabolism. Finally, we will be able to determine if dietary restriction is practical and results in greater specificity of ttMA as a benzene biomarker.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- 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.
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 23 Mar 2006.
- Background: PubMed 9646045Weaver VM, Buckley TJ, Groopman JD. Approaches to environmental exposure assessment in children. Environ Health Perspect. 1998 Jun;106 Suppl 3(Suppl 3):827-32. doi: 10.1289/ehp.98106827.
- Background: PubMed 8919771Weaver VM, Davoli CT, Heller PJ, Fitzwilliam A, Peters HL, Sunyer J, Murphy SE, Goldstein GW, Groopman JD. Benzene exposure, assessed by urinary trans,trans-muconic acid, in urban children with elevated blood lead levels. Environ Health Perspect. 1996 Mar;104(3):318-23. doi: 10.1289/ehp.96104318.
- Background: PubMed 10919747Weaver VM, Buckley T, Groopman JD. Lack of specificity of trans,trans-muconic acid as a benzene biomarker after ingestion of sorbic acid-preserved foods. Cancer Epidemiol Biomarkers Prev. 2000 Jul;9(7):749-55.
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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.
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 Lung Disease and Cancer, run by National Institute of Environmental Health Sciences (NIEHS) 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?
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 23 Mar 2006. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00014963, 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 23 Mar 2006.