- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042445
Brain Neoplasms, Leukemia and Petrochemical Exposures
September 1, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
The aim of this study is to examine the association of exposure to air contaminants (PAH & VOC) emitted from the petrochemical industries, specific genetic polymorphisms (P4501A1 (MspI & exon 7) and GSTM1 & T1) of study subjects and their parents, and the risks of brain tumors and leukemia among children and youths in metropolitan Kaohsiung, southern Taiwan.
Study Overview
Status
Completed
Conditions
Detailed Description
Brain tumors and leukemia are the most common malignancies among children and adolescents in the U.S. Adequate information on the role of inherited genetic susceptibility and environmental exposures in the development of neoplasms in children and adolescents is lacking.
In Taiwan, four large petrochemical industries are located in the Kaohsiung metropolitan area.
These facilities are proximal to residential areas because of the high population density in the region.
Data have shown that the concentrations of ambient polycyclic aromatic hydrocarbons (PAH) and volatile organic compounds (VOC) around the petrochemical industries are at least 10 and 2 times, respectively, higher than those in U.S. industrialized communities.
Our preliminary case-control study in metropolitan Kaohsiung showed that young residents (under age 30) living within 3 kilometers of the vicinity of petrochemical industries have a 6.0 fold increase in brain neoplasms and a 2.9 fold increase in leukemia.
The purpose of this proposal is to examine the association of exposure to air contaminants (PAH and VOC) emitted from the petrochemical industries, specific genetic polymorphisms (P4501A1 (MspI & exon 7) and GSTM1 &T1) from study subjects and their parents, and the risks of brain tumors and leukemia among children and youths in metropolitan Kaohsiung.
Our hypothesis is that there is an increased risk of brain tumors and leukemia in patients with high cumulative exposure to these hazards, and that heritable polymorphisms in several genes modify this association.
In addition to an independent association of environmental and genetic factors with brain neoplasms and leukemia, we hypothesize that there is greater risk associated with the presence of combined environmental exposure and the high risk genotype.
Also, we will assess the role of parental genetic polymorphisms in the development of cancer in their siblings.
This proposed study uses an environmental molecular epidemiologic approach, utilizing prospective enrollment of a cohort of brain tumor and leukemia subjects in a population-based case-control design.
This proposal is responsive to the recommendation of the National Research Council that risk assessment and public health policy pay special attention to the protection of children.
Study Type
Observational
Enrollment
1456
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 80708
- Kaohsiung Medical University
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Harvard School of Public Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Young population Less than 30 Resident of Kaohsiung metropolitan, Taiwan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2000
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
July 30, 2002
First Submitted That Met QC Criteria
July 31, 2002
First Posted (Estimate)
August 1, 2002
Study Record Updates
Last Update Posted (Estimate)
September 4, 2006
Last Update Submitted That Met QC Criteria
September 1, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9723-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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