Hematologic DiseasesNCT00364520
Molecular Epidemiology of Benzene-exposed Workers.
An observational study of Hematologic Diseases, run by University of Colorado, Denver at 1 site in China.
Trial summary
The purpose of this study is to investigate the health effects of benzene exposure in workers in Shanghai, China. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Shanghai workers
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2003to Dec 2009
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Shanghai Workers
Who may be able to join
- Worked for at least one year in a monitored environment Have at least one physical examination recorded
- -
Who cannot join
- History of cancer, radiation exposure, chemotherapy
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Joint Sino-US Clinical and Molecular Laboratory (JCML)
Shanghai, 200032
About this study
Official title: Molecular Epidemiology of Benzene-exposed Workers in Shanghai,China
The purpose of this study is to investigate the health effects of benzene exposure in workers in Shanghai, China.
Read the detailed description
The purpose of this study is to investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers and to characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.
- Conditions
- Hematologic Diseases
- Being tested
- Shanghai workers
- Keywords
- Hematologic Diseases, Benzene, Genetic Polymorphisms
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shanghai workersOther
| Study group | Role | What they receive |
|---|---|---|
| Shanghai Workers | Shanghai Workers Receives: Other: Shanghai workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers.
Investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers
Measured: August 2003 - December 2009
Secondary outcomes (1)
Characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.
Characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.
Measured: August 2003 - December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, University of Cincinnati, ExxonMobil Biomedical Sciences, Inc., British Petroleum P.L.C., Chevron Corporation, ConocoPhillips, Exxon Mobil, Marathon Ashland, Shell Chemicals
- Responsible party
- Sponsor
- Investigators
- Richard D Irons, PhD, Principal investigator, University of Colorado at Denver and Health Sciences Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364520
- Sponsor's protocol ID
- 02-0037
- Status last verified
- May 2007
- First submitted
- 14 Aug 2006
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology of Benzene-exposed Workers in Shanghai,China
- ClinicalTrials.gov ID
- NCT00364520
- Acronym / sponsor ID
- 02-0037
- Conditions
- Hematologic Diseases
- Keywords
- Hematologic Diseases, Benzene, Genetic Polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Fudan University, University of Cincinnati, ExxonMobil Biomedical Sciences, Inc., British Petroleum P.L.C., Chevron Corporation, ConocoPhillips, Exxon Mobil, Marathon Ashland, Shell Chemicals
- Study start
- Aug 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Aug 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 purpose of this study is to investigate the health effects of benzene exposure in workers in Shanghai, China.
Detailed description
The purpose of this study is to investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers and to characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shanghai Workers | – | Other: Shanghai workersShanghai Workers |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Shanghai Workers
Key inclusion criteria (2 listed)
- Worked for at least one year in a monitored environment Have at least one physical examination recorded
- -
Key exclusion criteria (2 listed)
- History of cancer, radiation exposure, chemotherapy
- -
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 |
|---|---|---|
| Shanghai workers | Other | Shanghai Workers |
Primary outcome
Investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers.
Time frame: August 2003 - December 2009
Investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers
1 secondary outcome
Characterize genetic polymorphisms that are associated with increased risk of developing benzene hematotoxicity.
Time frame: August 2003 - December 2009
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 21 May 2015.
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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.
Richard D Irons, PhD principal investigator
University of Colorado at Denver and Health Sciences Ctr
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 Hematologic Diseases, run by University of Colorado, Denver at 1 site in China.
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 2 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 21 May 2015. 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 China. 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?
Investigate the dose-response relationship between benzene exposure and blood diseases in Shanghai workers. (time frame: August 2003 - December 2009). It is what the study was designed to measure, not a finding.
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 21 May 2015.