Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341016
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2006-06-19
Brief Title:
Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident
Status:
COMPLETED
Status Verified Date:
2020-02
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:
None
Brief Summary:
Leukemia holds a special place in the study of radiation-related cancer because bone marrow is one of the tissues most sensitive to the carcinogenic effect of ionizing radiation radiogenic leukemia has the shortest latent period among radiation-induced cancers and its appearance suggests that solid tumors may follow These same characteristics also contribute to its considerable significance in radiation protection There are nevertheless important gaps in existing knowledge of radiation-induced leukemia gaps that derive from characteristics of the study of the atomic bombing of Hiroshima and Nagasaki and from studies of the effects of medical irradiation and studies of nuclear workers these being the studies that have provided most of the information to date These gaps include the presumed reduction in risk resulting from dose-fractionation and low dose-rate and the time-response function in the first five years after exposure
The primary objective of this study is to investigate leukemia risk as a function of such radiation it would constitute the largest epidemiologic study conducted to date among working-age males a group of particular concern in establishing occupational radiation safety standards In addition data on cases of multiple myeloma and myelodysplasia identified in the cohort will be collected to test the hypothesis of a dose related association between radiation and increased risk for each of these diseases
The primary scientific objectives of the proposed study are to test the following hypotheses a that there is a dose-related increase in risk of leukemia among these liquidators b that the magnitude of any observed risk per unit dose is less than that seen in the atomic bomb survivors exposed to essentially instantaneous radiation
Subsidiary objectives include a to investigate the nature of the dose-response relationship among liquidators and to identify modifiers of risk including time since exposure age at exposure etc b to test the hypothesis that there is a dose-related increased risk of multiple myeloma c to test the hypothesis that there is a dose-related increased risk of myelodysplasial d to collect and store buccal cells from about 2000 liquidators with a wide range of dose estimates extending to well over 1 Gy for possible use in future molecular studies of their DNA
The primary objective of this study is to investigate leukemia risk as a function of such radiation it would constitute the largest epidemiologic study conducted to date among working-age males a group of particular concern in establishing occupational radiation safety standards In addition data on cases of multiple myeloma and myelodysplasia identified in the cohort will be collected to test the hypothesis of a dose related association between radiation and increased risk for each of these diseases
The primary scientific objectives of the proposed study are to test the following hypotheses a that there is a dose-related increase in risk of leukemia among these liquidators b that the magnitude of any observed risk per unit dose is less than that seen in the atomic bomb survivors exposed to essentially instantaneous radiation
Subsidiary objectives include a to investigate the nature of the dose-response relationship among liquidators and to identify modifiers of risk including time since exposure age at exposure etc b to test the hypothesis that there is a dose-related increased risk of multiple myeloma c to test the hypothesis that there is a dose-related increased risk of myelodysplasial d to collect and store buccal cells from about 2000 liquidators with a wide range of dose estimates extending to well over 1 Gy for possible use in future molecular studies of their DNA
Detailed Description:
Leukemia holds a special place in the study of radiation-related cancer because bone marrow is one of the tissues most sensitive to the carcinogenic effect of ionizing radiation Radiogenic leukemia has the shortest latent period among radiation-induced cancers and its appearance suggests that solid tumors may follow These same characteristics also contribute to its considerable significance in radiation protection There are nevertheless important gaps in existing knowledge of radiation-induced leukemia gaps that derive from characteristics of the study of the atomic bombing of Hiroshima and Nagasaki and from studies of the effects of medical irradiation and studies of nuclear workers these are the studies that have provided most of the information to date The gaps include the presumed reduction in risk resulting from dose-fractionation and low dose-rate as well as the time- response function in the first five years after exposure The study described herein is intended to fill those gaps
The Chornobyl accident exposed hundreds of thousands of people to radiation notably those involved in its cleanup operations The second phase of a case-control study of ionizing radiation and leukemia is being conducted in a cohort of approximately 100000 Ukrainian liquidators involved in cleanup work following the accident at the Chornobyl Nuclear Power Plant in northern Ukraine which occurred on April 26 1986 The cohort is restricted to liquidators who first worked around the power plant between 1986 and 1990 and were residents when first registered in the Chornobyl State Registry in Kyiv City or in one of five oblasts major civil divisions that comprise the study area This cohort consisting of males of working age received mean bone marrow doses of approximately 80-100 milli-gray mGy at low to moderate dose rates with those sent earlier receiving the highest doses The primary objective of this study is to investigate leukemia risk as a function of such radiation it constitutes probably the largest epidemiologic study conducted to date among working-age males a group of particular concern in establishing occupational radiation safety standards
The primary scientific objectives of the proposed study are to evaluate whether there is a doserelated increase in risk of leukemia among these liquidators and how it compares with the observed risk per unit dose seen in the atomic bomb survivors exposed to essentially instantaneous radiation A secondary objective is to identify any modifiers of risk including time since exposure age at exposure etc
The field work for the second phase of the study with an extended case ascertainment for 2001 through 2006 has been complated As a result of the second phase a total of75 confirmed cases of leukemia and 12 cases of multiple myeloma have been ascertained We are currently in the process of database construction dosimetric calculation for data analyses for leukemia and manuscript preparation
The small sub-study on uncertainties associated with human factors is to be started upon SSIRB approval
The Chornobyl accident exposed hundreds of thousands of people to radiation notably those involved in its cleanup operations The second phase of a case-control study of ionizing radiation and leukemia is being conducted in a cohort of approximately 100000 Ukrainian liquidators involved in cleanup work following the accident at the Chornobyl Nuclear Power Plant in northern Ukraine which occurred on April 26 1986 The cohort is restricted to liquidators who first worked around the power plant between 1986 and 1990 and were residents when first registered in the Chornobyl State Registry in Kyiv City or in one of five oblasts major civil divisions that comprise the study area This cohort consisting of males of working age received mean bone marrow doses of approximately 80-100 milli-gray mGy at low to moderate dose rates with those sent earlier receiving the highest doses The primary objective of this study is to investigate leukemia risk as a function of such radiation it constitutes probably the largest epidemiologic study conducted to date among working-age males a group of particular concern in establishing occupational radiation safety standards
The primary scientific objectives of the proposed study are to evaluate whether there is a doserelated increase in risk of leukemia among these liquidators and how it compares with the observed risk per unit dose seen in the atomic bomb survivors exposed to essentially instantaneous radiation A secondary objective is to identify any modifiers of risk including time since exposure age at exposure etc
The field work for the second phase of the study with an extended case ascertainment for 2001 through 2006 has been complated As a result of the second phase a total of75 confirmed cases of leukemia and 12 cases of multiple myeloma have been ascertained We are currently in the process of database construction dosimetric calculation for data analyses for leukemia and manuscript preparation
The small sub-study on uncertainties associated with human factors is to be started upon SSIRB approval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH96-C-N030 | None | None | None |