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Molecular Epidemiology of Childhood Leukemia (Aka The California Childhood Leukemia Study) (CCLS)

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ClinicalTrials.gov Identifier: NCT00015587
Recruitment Status : Completed
First Posted : April 25, 2001
Last Update Posted : October 12, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Institute of Environmental Health Sciences (NIEHS)

Brief Summary:
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 - University of California Berkeley in collaboration with the California Department of Health Services and 16 hospitals located throughout the state of California. The study began in 1995 and will continue to 2014.

Condition or disease
Leukemia Acute Myelocytic Leukemia Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia

Detailed Description:

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 the state of California 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. The lab 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.

One comparison subject (control) is 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; mothers' reproductive history; events during index pregnancy and delivery; family history of illness; child's health and vaccination history, contact with other children; maternal and child exposure to cigarette smoke during pregnancy and since birth; maternal and child history of x-rays.

Saliva specimens are obtained from both cases and controls and their biological mothers. The saliva samples are sent to the study office and processed in the Genetic Epidemiology lab at UC Berkeley. 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.

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Study Type : Observational
Actual Enrollment : 3523 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Chemical Exposures and Leukemia Risks and Childhood Leukemia and Environmental Exposure
Study Start Date : April 1995
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Primary Outcome Measures :
  1. Outcome of study [ Time Frame: duration of study ]
    Using a case-control study design, we are studying the role of environmental and genetic factors in the etiology of a rare cancer in a vulnerable and ethnically diverse population, using an integrated multi-disciplinary approach to improve disease classification and exposure assessment.

Biospecimen Retention:   Samples With DNA
pre-treatment peripheral blood and bone marrow saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children diagnosed with leukemia and matched controls

Cases must be children ages 0-14 newly diagnosed with leukemia (any type) at one of participating hospitals. They must live in the state of California at diagnosis, 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 the state of California.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015587

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United States, California
University of California, School of Public Health, Childhood Leukemia Study
Berkeley, California, United States, 94720-7392
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
National Cancer Institute (NCI)
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Principal Investigator: Catherine Metayer, MD, PhD University of California Berkeley, School of Public Health
Publications of Results:

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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00015587    
Other Study ID Numbers: 9137-CP-001
First Posted: April 25, 2001    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Molecular Epidemiology
Case Control
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases