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Home > "M" Clinical Trials Conditions > Molecular Epidemiology of Childhood Leukemia in Northern and Central California  Molecular Epidemiology of Childhood Leukemia in Northern and Central California
Molecular Epidemiology of Childhood Leukemia in Northern and Central California
For Condition: Acute Lymphoblastic Leukemia,Acute Myelogenous Leukemia,Acute Myelocytic Leukemia,Leukemia
Status: Recruiting
Sponsor(s): National Institute of Environmental Health Sciences (NIEHS) , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Case Control, Prospective Study
Minimum Age/Maximum Age: /14 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 1200
Location and Contact Information:
Overall Study Official:
PatriciaBuffler, Principal Investigator, University of California Berkeley, School of Public Health
Children's Hospital Oakland, Pediatric Oncology/Hematology *Recruiting*
Oakland, California, 94609
United States
Recruiting Jim Fuesner 510-428-3689
California Dept. of Health Services, Environmental Health Investigations Branch *Recruiting*
Oakland, California, 94612
United States
Recruiting Peggy Reynolds 510-622-4417
University of California, School of Public Health, Childhood Leukemia Study *Recruiting*
Berkeley, California, 94720-7380
United States
Recruiting Karen Pfister 510-642-6167
Additional Information:
Study ID Numbers: 9137-CP-001;
Study Start Date: April 1995
Record last reviewed: November 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015587
Other Leukemia Studies:
1. Molecular Epidemiology of Childhood Leukemia in Northern and Central California
Related Studies:
Other Leukemia Clinical Trials
Other California Clinical Trials
Other Oakland Clinical Trials
Molecular Epidemiology of Childhood Leukemia in Northern and Central California
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