Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015587
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2001-04-23
Brief Title:
Molecular Epidemiology of Childhood Leukemia Aka The California Childhood Leukemia Study
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institute of Environmental Health Sciences NIEHS
Study Overview
Official Title:
Chemical Exposures and Leukemia Risks and Childhood Leukemia and Environmental Exposure
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCLS
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
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 t922 and t821 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 mothers 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 childs 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
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 mothers 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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None