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Urban Environmental Exposures and Childhood Cancer

This study has been completed.
Sponsor:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00505141
First received: July 20, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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.


Condition
Brain Cancer
Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Case-Control Study of Urban Environmental Effects on Childhood Leukemia and Brain Cancer

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Study Start Date: September 2004
Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505141

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Offie P Soldin Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00505141     History of Changes
Other Study ID Numbers: 2004-278
Study First Received: July 20, 2007
Last Updated: July 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Childhood Brain Cancer
Childhood Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Brain Neoplasms
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014