This study is a case-control study investigating the causes of childhood leukemia in Northern California. The overall purpose of this epidemiologic study is to find specific genetic or environmental factors that may increase the risk of leukemia in children. The study is being conducted by Patricia Buffler, PhD at the School of Public Health, the University of California Berkeley, with collaboration by the California Department of Health Services and nine other Bay Area and Central Valley hospitals. The study began in 1995 and will continue to 2003.

Condition
Leukemia Acute Myelocytic Leukemia Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia

Further Study Details: 

Expected Total Enrollment:  1200

This study is a case-control study of incident childhood leukemia (all subtypes) diagnosed since mid-1995. Children newly diagnosed with leukemia are enrolled in the study. Criteria for inclusion in the study are: under 15 years of age, no prior cancer diagnosis, residency in one of 35 counties at the time of diagnosis, and availability of an English or Spanish speaking parent or guardian. Pre-treatment biological specimens including bone marrow and peripheral blood are obtained for analysis in the UCB lab of Dr. M. Smith. He will use Fluorescence In Situ Hybridization (FISH) to detect chromosome specific aneuploidy and translocations. A number of chromosomal translocations, including t(9;22) and t(8;21), are known to be centrally involved in the development of childhood leukemia. Molecular characterization of the cases with translocations may provide insight into the timing of critical exposures and the nature of the etiological agent involved.

Two comparison subjects (controls) are recruited for each consenting case. For each case, four potential controls are randomly selected from California birth certificate files and matched on date of birth, gender, mother's race, parental Hispanicity, and county of residence. One of the four birth certificate controls is randomly selected to be recruited to participate in the study.

An in-depth personal interview asks a variety of questions, including: residential history; occupational and household exposure histories; dietary history of child until the age of three and biological mother at the time of conception and during pregnancy; mothers' reproductive history; events during index pregnancy and delivery; family history of illness; child's health and vaccination history, contact with other children, and location of schools; maternal and child exposure to cigarette smoke during pregnancy and since birth; maternal and child history of x-rays; and hobby and craft exposures during pregnancy until age three. Buccal cell specimens are obtained from the cases and controls and their biological mothers. The buccal cells are sent to Dr. J. Wiencke's Lab of Molecular Epidemiology at UCSF. DNA from cases and controls will be analyzed by polymerase chain reaction for genetic polymorphisms. Genetic polymorphisms will be examined in two glutathione transferase genes, M1 and Tl. Case samples of peripheral blood, bone marrow, and archived newborn blood will be also used to detect N-ras mutation.

Three tiers of an exposure assessment are being implemented. Tier 1 enrolls and interviews cases and controls seeking to identify risk factors, including residential and occupational chemical exposures. In Tier 2, cases and birth certificate controls that have not changed residence based on specific criteria are part of a reliability study, which seeks to determine if self-reported chemicals used at the time of interview are found in the home during a visual survey several months after interview. Tier 3 aims to document the potential for household exposures by sampling dust on the floor surfaces. The objective is to identify if there are differences in concentrations of pesticides, metals, polyaromatic hydrocarbons, cotinine, polychorinated biphenyls, and ethylenethiourea in the homes of cases and controls. Further, a case-case analysis will identify if cases with chromosomal translocations of interest live in homes with higher concentrations of target compounds than cases that do not have such translocations. These analyses will determine whether leukemic children with common genetic changes experience common exposures and whether these genetic changes have approximately the same temporal occurrence. Finally, we will evaluate whether children with and without leukemia differ with respect to susceptibility.

Ages Eligible for Study:  up to  14 Years,  Genders Eligible for Study:  Both

Criteria

Cases must be children ages 0-14 newly diagnosed with leukemia (any type) at one of participating hospitals. They must live in one of 35 No. California counties, never have been diagnosed with a prior cancer and have a parent or guardian that speaks English or Spanish.

Controls are matched on the case child's DOB, gender, mother's race, parent's Hispanicity. In order to be eligible, they must have no history of cancer, have a parent or guardian that speaks English or Spanish and they must live in one of 35 No. California counties.

Monique B Does, Project Manager      510-643-8399    mobuff@uclink.berkeley.edu

California
      University of California, School of Public Health, Childhood Leukemia Study, Berkeley,  California,  94720-7380,  United States; Recruiting
      California Dept. of Health Services, Environmental Health Investigations Branch, Oakland,  California,  94612,  United States; Recruiting
      Children's Hospital Oakland, Pediatric Oncology/Hematology, Oakland,  California,  94609,  United States; Recruiting

Study chairs or principal investigators

Patricia A Buffler, PhD,  Principal Investigator,  University of California Berkeley, School of Public Health   

Study ID Numbers:  9137-CP-001
Record last reviewed:  November 2000
Last Updated:  October 13, 2004
Record first received:  April 23, 2001
ClinicalTrials.gov Identifier:  NCT00015587
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08