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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by National Institute of Environmental Health Sciences (NIEHS)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00015587
First received: April 23, 2001
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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
Leukemia
Acute Myelocytic Leukemia
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Chemical Exposures and Leukemia Risks and Childhood Leukemia and Environmental Exposure

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Primary Outcome Measures:
  • Outcome of study [ Time Frame: duration of study ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1320
Study Start Date: April 1995
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children diagnosed with leukemia and matched controls

Criteria

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.

  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: NCT00015587

Contacts
Contact: Pagan Morris, MPH, CHES 888-510-2257 ccls@berkeley.edu

Locations
United States, California
University of California, School of Public Health, Childhood Leukemia Study Recruiting
Berkeley, California, United States, 94720-7392
Contact: Pagan Morris, MPH    888-510-2257    ccls@berkeley.edu   
Principal Investigator: Catherine Metayer, MD, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Catherine Metayer, MD, PhD University of California Berkeley, School of Public Health
  More Information

Publications:

Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00015587     History of Changes
Other Study ID Numbers: 9137-CP-001
Study First Received: April 23, 2001
Last Updated: October 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Molecular Epidemiology
Case Control

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

ClinicalTrials.gov processed this record on October 23, 2014