Radiation ExposureNCT00481793
Relationship of Genetic Differences to the Development of Chromosome Abnormalities
An observational study of Radiation Exposure, run by National Cancer Institute (NCI) at 1 site in Russia.
Trial summary
This is a collaborative study by the National Cancer Institute, Columbia University, and the Southern Urals Biophysics Institute in Russia. It will examine the relationship of differences in certain genes to the development of chromosomal abnormalities in workers at the Mayak nuclear production plant in Ozyorsk… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Exposure
- How many people
- 361 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jun 2004to 17 Sep 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals eligible to be included in the 'exposed' population include all those employed from 1948-1972 in the three plants directly related to nuclear-weapon production (nuclear reactor, radiochemical production plant, plutonium production plant), who have remained local residents, and who have estimates of their external gamma dose and internal plutonium exposure.
- Some eligible workers did not have any plutonium exposure, but are still eligible to be included in the exposed sample due to their external radiation exposure.
- All participants are required to be cancer-free at the time of enrollment.
- The comparison population will be drawn from current and former workers in the auxiliary plants (water treatment facility and mechanical repair plant) at the Mayak facility.
- Included will be a stratified random sample of these workers who were employed from 1948-1972, who have remained local residents, and who have estimates of their external gamma dose.
- Individuals selected will be frequency-matched according to age (5 year age groups) and gender to the exposed worker population.
Who cannot join
- Individuals who have a medical history of radiation therapy or a blood transfusion within the previous year will be excluded.
- As the sample size would not be adequate to examine their risk separately, Tartars and Bashkirs will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Germline Genetic Variation and Risk of Chromosome Aberrations Among Mayak Nuclear Workers
This is a collaborative study by the National Cancer Institute, Columbia University, and the Southern Urals Biophysics Institute in Russia. It will examine the relationship of differences in certain genes to the development of chromosomal abnormalities in workers at the Mayak nuclear production plant in Ozyorsk, Russia. This population was exposed to higher radiation doses from external and internal sources than those received by their counterparts in other countries or considered permissible today. If a risk relationship is found between genetic differences and chromosome abnormalities, the information might be useful in studies designed to examine how high radiation exposures cause cancer.
Radiation-exposed Mayak workers employed from 1948 to 1972 in the three Ozyorsk plants directly related to nuclear weapons production may be eligible for this study. They must have remained local residents in the area and estimates of their external and internal radiation exposures must be available.
Read more
Participants provide a blood sample for genetic studies and answer a questionnaire that includes demographic information and information about their family health history, history of benign tumors, if any, and history of smoking and alcohol consumption. Additional information is collected from patients' medical records.
...
Read the detailed description
Greater understanding of the role of individual variation in response to radiation exposure might clarify the inconsistent relationship between radiation dose, intermediate markers of induced DNA damage, and subsequent cancer risk. REB proposes to collaborate with Columbia University and the Southern Urals Biophysics Institute to elucidate the contribution of germline genetic variation to the frequency of chromosomal aberrations in a cohort of Russian nuclear workers with notable and atypical radiation exposures. Our collaborators are utilizing a new biodosimetry method, termed mBAND, to measure intra-chromosomal aberrations, a potentially useful biomarker of exposure to high linear energy transfer radiation such as plutonium. In addition, they will assess inter-chromosomal aberrations using mFISH (multicolor fluorescent insitu hybridization). As factors other than radiation dose may influence aberration frequency, REB proposes to add to this DOE-funded study an investigation of germline genetic variation in DNA repair and other genes in relation to aberration risk. Mayak nuclear workers (n = approximately 350) employed from 1948-72 will receive a short questionnaire and have a blood sample drawn while receiving routine annual medical exams. Germline genotype will be assessed as a risk factor for chromosome aberration frequency. In this study, we have the opportunity to address scientific questions regarding radiation carcinogenesis mechanisms at relatively little cost in a population with rare, higher dose exposures.
- Conditions
- Radiation Exposure
- Keywords
- Plutonium, Ionizing Radiation, Polymorphism, Biological Marker, Russia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study start9 Jun 2004
- Study completion17 Sep 2014
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 Radiation ExposureStudies 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
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Martha Linet, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481793
- Sponsor's protocol ID
- 999904215
- Other IDs
- 04-C-N215
- Status last verified
- 17 Sep 2014
- First submitted
- 1 Jun 2007
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Bonassi S, Hagmar L, Stromberg U, Montagud AH, Tinnerberg H, Forni A, Heikkila P, Wanders S, Wilhardt P, Hansteen IL, Knudsen LE, Norppa H. Chromosomal aberrations in lymphocytes predict human cancer independently of exposure to carcinogens. European Study Group on Cytogenetic Biomarkers and Health. Cancer Res. 2000 Mar 15;60(6):1619-25.
PubMed 10749131Cardis E, Gilbert ES, Carpenter L, Howe G, Kato I, Armstrong BK, Beral V, Cowper G, Douglas A, Fix J, et al. Effects of low doses and low dose rates of external ionizing radiation: cancer mortality among nuclear industry workers in three countries. Radiat Res. 1995 May;142(2):117-32.
PubMed 7724726Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.
PubMed 9875838
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Germline Genetic Variation and Risk of Chromosome Aberrations Among Mayak Nuclear Workers
- ClinicalTrials.gov ID
- NCT00481793
- Acronym / sponsor ID
- 999904215
- Conditions
- Radiation Exposure
- Keywords
- Plutonium, Ionizing Radiation, Polymorphism, Biological Marker, Russia
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 361 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Jun 2004
- Study completion
- 17 Sep 2014
- First posted
- 4 Jun 2007 (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.
This is a collaborative study by the National Cancer Institute, Columbia University, and the Southern Urals Biophysics Institute in Russia. It will examine the relationship of differences in certain genes to the development of chromosomal abnormalities in workers at the Mayak nuclear production plant in Ozyorsk, Russia. This population was exposed to higher radiation doses from external and internal sources than those received by their counterparts in other countries or considered permissible today. If a risk relationship is found between genetic differences and chromosome abnormalities, the information might be useful in studies designed to examine how high radiation exposures cause cancer.
Radiation-exposed Mayak workers employed from 1948 to 1972 in the three Ozyorsk plants directly related to nuclear weapons production may be eligible for this study. They must have remained local residents in the area and estimates of their external and internal radiation exposures must be available.
Participants provide a blood sample for genetic studies and answer a questionnaire that includes demographic information and information about their family health history, history of benign tumors, if any, and history of smoking and alcohol consumption. Additional information is collected from patients' medical records.
...
Detailed description
Greater understanding of the role of individual variation in response to radiation exposure might clarify the inconsistent relationship between radiation dose, intermediate markers of induced DNA damage, and subsequent cancer risk. REB proposes to collaborate with Columbia University and the Southern Urals Biophysics Institute to elucidate the contribution of germline genetic variation to the frequency of chromosomal aberrations in a cohort of Russian nuclear workers with notable and atypical radiation exposures. Our collaborators are utilizing a new biodosimetry method, termed mBAND, to measure intra-chromosomal aberrations, a potentially useful biomarker of exposure to high linear energy transfer radiation such as plutonium. In addition, they will assess inter-chromosomal aberrations using mFISH (multicolor fluorescent insitu hybridization). As factors other than radiation dose may influence aberration frequency, REB proposes to add to this DOE-funded study an investigation of germline genetic variation in DNA repair and other genes in relation to aberration risk. Mayak nuclear workers (n = approximately 350) employed from 1948-72 will receive a short questionnaire and have a blood sample drawn while receiving routine annual medical exams. Germline genotype will be assessed as a risk factor for chromosome aberration frequency. In this study, we have the opportunity to address scientific questions regarding radiation carcinogenesis mechanisms at relatively little cost in a population with rare, higher dose exposures.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals eligible to be included in the 'exposed' population include all those employed from 1948-1972 in the three plants directly related to nuclear-weapon production (nuclear reactor, radiochemical production plant, plutonium production plant), who have remained local residents, and who have estimates of their external gamma dose and internal plutonium exposure.
- Some eligible workers did not have any plutonium exposure, but are still eligible to be included in the exposed sample due to their external radiation exposure.
- All participants are required to be cancer-free at the time of enrollment.
- The comparison population will be drawn from current and former workers in the auxiliary plants (water treatment facility and mechanical repair plant) at the Mayak facility.
- Included will be a stratified random sample of these workers who were employed from 1948-1972, who have remained local residents, and who have estimates of their external gamma dose.
Key exclusion criteria (2 listed)
- Individuals who have a medical history of radiation therapy or a blood transfusion within the previous year will be excluded.
- As the sample size would not be adequate to examine their risk separately, Tartars and Bashkirs will not be included in the study.
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 10749131Bonassi S, Hagmar L, Stromberg U, Montagud AH, Tinnerberg H, Forni A, Heikkila P, Wanders S, Wilhardt P, Hansteen IL, Knudsen LE, Norppa H. Chromosomal aberrations in lymphocytes predict human cancer independently of exposure to carcinogens. European Study Group on Cytogenetic Biomarkers and Health. Cancer Res. 2000 Mar 15;60(6):1619-25.
- Background: PubMed 7724726Cardis E, Gilbert ES, Carpenter L, Howe G, Kato I, Armstrong BK, Beral V, Cowper G, Douglas A, Fix J, et al. Effects of low doses and low dose rates of external ionizing radiation: cancer mortality among nuclear industry workers in three countries. Radiat Res. 1995 May;142(2):117-32.
- Background: PubMed 9875838Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.
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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.
Martha Linet, 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 Radiation Exposure, run by National Cancer Institute (NCI) at 1 site in Russia.
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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 17 Dec 2019. 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 Russia. 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481793, 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 17 Dec 2019.