LeukemiaNCT00341016
Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident
An observational study of Leukemia, run by National Cancer Institute (NCI) at 1 site in Ukraine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leukemia
- How many people
- 1,779 participants
- Where
- 1 siteUkraine
- Study dates
- 26 Aug 1996to 12 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ukrainian Chernobyl cleanup workers ("liquidators") approx. 100,000 persons
Who may be able to join
- We intend to include in the proposed study all 350 clean-up workers with "historical" records and 150 proxies to be identified by the liquidators; however, we anticipate a considerable number of them will not be available for the study due to deaths, not being able to be traced, no response, refusals, etc. The study subjects will be interviewed in person. All study subjects are males, median age of early liquidators is 64 y while for clean-up workers sent to mission is about 61 years.
Who cannot join
- Excluded from the study will be those who have been found to be deceased, cannot be located, refuse to participate in the study, or do not provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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 2,000 liquidators with a wide range of dose estimates extending to well over 1 Gy for possible use in future molecular studies of their DNA.
Read the 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 100,000 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.
- Conditions
- Leukemia
- Keywords
- Radiation
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of Chernobyl cleanup workers (liquidators) in Ukraine | Cases with leukemia and related diseases, and matched controls in the cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to investigate leukemia risk as a function of radiation ionizing radiation from occupational exposure (Chernobyl nuclear power plant)
Estimated risk of leukemia related to radiation exposure
Measured: time of interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start26 Aug 1996
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kiyohiko Mabuchi, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341016
- Sponsor's protocol ID
- 999996030
- Other IDs
- OH96-C-N030
- Status last verified
- Feb 2020
- First submitted
- 19 Jun 2006
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gudzenko N, Hatch M, Bazyka D, Dyagil I, Reiss RF, Brenner A, Chumak V, Babkina N, Zablotska LB, Mabuchi K. Non-radiation risk factors for leukemia: A case-control study among chornobyl cleanup workers in Ukraine. Environ Res. 2015 Oct;142:72-6. doi: 10.1016/j.envres.2015.06.019. Epub 2015 Jun 24.
PubMed 26117815Chumak VV, Romanenko AY, Voilleque PG, Bakhanova EV, Gudzenko N, Hatch M, Zablotska LB, Golovanov IA, Luckyanov NK, Sholom SV, Kryuchkov VP, Bouville A. The Ukrainian-American study of leukemia and related disorders among Chornobyl cleanup workers from Ukraine: II. Estimation of bone marrow doses. Radiat Res. 2008 Dec;170(6):698-710. doi: 10.1667/RR1403.1.
PubMed 19138037Zablotska LB, Bazyka D, Lubin JH, Gudzenko N, Little MP, Hatch M, Finch S, Dyagil I, Reiss RF, Chumak VV, Bouville A, Drozdovitch V, Kryuchkov VP, Golovanov I, Bakhanova E, Babkina N, Lubarets T, Bebeshko V, Romanenko A, Mabuchi K. Radiation and the risk of chronic lymphocytic and other leukemias among chornobyl cleanup workers. Environ Health Perspect. 2013 Jan;121(1):59-65. doi: 10.1289/ehp.1204996. Epub 2012 Nov 8.
PubMed 23149165
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Protocol for the Study of Leukemia and Other Hematologic Diseases Among Clean-up Workers in Ukraine Following the Chernobyl Accident
- ClinicalTrials.gov ID
- NCT00341016
- Acronym / sponsor ID
- 999996030
- Conditions
- Leukemia
- Keywords
- Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,779 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Aug 1996 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 2,000 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 100,000 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of Chernobyl cleanup workers (liquidators) in Ukraine | – | –Cases with leukemia and related diseases, and matched controls in the cohort |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ukrainian Chernobyl cleanup workers ("liquidators") approx. 100,000 persons
Key inclusion criteria (1 listed)
- We intend to include in the proposed study all 350 clean-up workers with "historical" records and 150 proxies to be identified by the liquidators; however, we anticipate a considerable number of them will not be available for the study due to deaths, not being able to be traced, no response, refusals, etc. The study subjects will be interviewed in person. All study subjects are males, median age of early liquidators is 64 y while for clean-up workers sent to mission is about 61 years.
Key exclusion criteria (1 listed)
- Excluded from the study will be those who have been found to be deceased, cannot be located, refuse to participate in the study, or do not provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective of this study is to investigate leukemia risk as a function of radiation ionizing radiation from occupational exposure (Chernobyl nuclear power plant)
Time frame: time of interview
Estimated risk of leukemia related to radiation exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Background: PubMed 26117815Gudzenko N, Hatch M, Bazyka D, Dyagil I, Reiss RF, Brenner A, Chumak V, Babkina N, Zablotska LB, Mabuchi K. Non-radiation risk factors for leukemia: A case-control study among chornobyl cleanup workers in Ukraine. Environ Res. 2015 Oct;142:72-6. doi: 10.1016/j.envres.2015.06.019. Epub 2015 Jun 24.
- Background: PubMed 19138037Chumak VV, Romanenko AY, Voilleque PG, Bakhanova EV, Gudzenko N, Hatch M, Zablotska LB, Golovanov IA, Luckyanov NK, Sholom SV, Kryuchkov VP, Bouville A. The Ukrainian-American study of leukemia and related disorders among Chornobyl cleanup workers from Ukraine: II. Estimation of bone marrow doses. Radiat Res. 2008 Dec;170(6):698-710. doi: 10.1667/RR1403.1.
- Background: PubMed 23149165Zablotska LB, Bazyka D, Lubin JH, Gudzenko N, Little MP, Hatch M, Finch S, Dyagil I, Reiss RF, Chumak VV, Bouville A, Drozdovitch V, Kryuchkov VP, Golovanov I, Bakhanova E, Babkina N, Lubarets T, Bebeshko V, Romanenko A, Mabuchi K. Radiation and the risk of chronic lymphocytic and other leukemias among chornobyl cleanup workers. Environ Health Perspect. 2013 Jan;121(1):59-65. doi: 10.1289/ehp.1204996. Epub 2012 Nov 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyohiko Mabuchi, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by National Cancer Institute (NCI) at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to investigate leukemia risk as a function of radiation ionizing radiation from occupational exposure (Chernobyl nuclear power plant) (time frame: time of interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341016, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.