- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00505141
Urban Environmental Exposures and Childhood Cancer
Case-Control Study of Urban Environmental Effects on Childhood Leukemia and Brain Cancer
The Environmental Protection Agency has recognized that organophosphorus pesticides require close regulation and continued monitoring for human health effects and some (e.g chlorpyrifos) have been phased-out from the consumer market due to the special risk that it posed for children. There is growing evidence in support of the association between pesticide exposure and childhood leukemia. Studies of pesticides and their association with childhood cancer have been limited by study designs, self-reporting and lack of biological measurements. While several large studies in California found little evidence of an association between agricultural pesticide use and childhood leukemia, these results are in contrast with the associations observed with household exposures to pesticides. The real association may depend on timing of exposure, type of pesticide, dose and pathway of exposure. Furthermore, some persons may be more susceptible to the effects of specific pesticides due to inherited mutations in their detoxification pathways.
We are conducting a pilot study to test the hypothesis that environmental exposure to pesticides in pregnancy or during the neonatal period, together with genetic susceptibility may lead to childhood ALL or brain cancer. The study is a multicenter, case-control study, based on collaboration between clinical researchers and basic science research to evaluate the risk for childhood cancer in relation to measured levels of pesticides (and their metabolites) and genetic polymorphisms. Biomarkers will be used to examine the risks of chronic low-dose exposures, and to characterize relationships between specific pesticides, childhood cancer and genetic susceptibility.
Hypothesis: Interaction between environmental factors (pesticides) and maternal or child genetic polymorphisms may lead to childhood cancer.
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Only newly diagnosed cases of ALL and brain cancers (i.e. diagnosed within the previous 12 months) under the age of 18 years are eligible for this study. These will include live born infants at term or born prematurely, and any cases we are able to ascertain from pediatric hematology records.
- Healthy controls of similar age will be recruited.
- The children must have a parent available to be interviewed who speaks English or Spanish well enough to understand the questionnaire.
Exclusion criteria:
- Subjects with a diagnosis of Down syndrome or other chromosomal disorder, single gene disorder, or recognized multi-organ syndrome will be excluded.
- Non-residents of Maryland, the District of Columbia, and Virginia will be excluded; this will avoid the inclusion of out-of-state case families who traveled a long distance for clinical care, where control sampling would be problematic.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Offie P Soldin, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Leukemia
- Brain Neoplasms
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
Other Study ID Numbers
- 2004-278
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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