LeukemiaNCT00042445
Brain Neoplasms, Leukemia and Petrochemical Exposures
An observational study of Leukemia and Brain Neoplasm, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 30 years
- Conditions the study is for
- Leukemia, Brain Neoplasm
- How many people
- 1,456 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2000to Jul 2005
- 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 0 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Young population Less than 30 Resident of Kaohsiung metropolitan, Taiwan
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Harvard School of Public Health
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Leukemia, Brain Neoplasm
- Keywords
- Neoplasm, Petrochemical, Leukemia, Taiwan
- Medical subject headings
- Leukemia, Brain Neoplasms, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2002 (estimated)
- Study startAug 2000
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Observational model
- Case-control
- Enrolment
- 1,456 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Harvard School of Public Health (HSPH), Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042445
- Sponsor's protocol ID
- 9723-CP-001
- Status last verified
- Sep 2006
- First submitted
- 30 Jul 2002
- Last updated
- 4 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Neoplasms, Leukemia and Petrochemical Exposures
- ClinicalTrials.gov ID
- NCT00042445
- Acronym / sponsor ID
- 9723-CP-001
- Conditions
- Leukemia, Brain Neoplasm
- Keywords
- Neoplasm, Petrochemical, Leukemia, Taiwan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,456 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Collaborators
- Harvard School of Public Health (HSPH), Kaohsiung Medical University
- Study start
- Aug 2000
- Study completion
- Jul 2005
- First posted
- 1 Aug 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 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.
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 design
- Observational model
- Case-control
Who may qualify
- Ages
- 0 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 4 Sep 2006.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Brain Neoplasm, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in 2 countries.
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 4 Sep 2006. 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, Taiwan. 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?
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 4 Sep 2006.