Thyroid CancerNCT00480428
Radiation Exposure and Thyroid Disease in Kazakhstan
An observational study of Thyroid Cancer and Thyroid Nodules, run by National Cancer Institute (NCI) at 1 site in Kazakhstan.
Trial summary
Residents of certain villages in Kazakhstan were exposed during childhood to radioactive fallout from nuclear tests conducted at the Semipalatinsk Nuclear Test Site (SNTS) between 1949 and 1962. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodules, Other Thyroid Disease
- How many people
- 117 participants
- Where
- 1 siteKazakhstan
- Study dates
- 17 May 2007to 17 Aug 2017
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
- To be eligible, individuals must speak Russian or Kazakh, be able to participate in a two-hour focus group session, and have a verified history of residing in the village during the 1950s. Verification of residence history will be based on regional records.
- Women: In each village, we will recruit 24 women. We will select women who are age 70 years and older and who had children or provided care to children (i.e., younger siblings, nieces and nephews) during the 1950s. Our first priority is to recruit women whose own children were less than 21 years during the 1950s. If necessary, we will also recruit women who provided care to children other than their own (e.g., younger siblings, nieces and nephews) during this period. We will recruit both members of our 1998 cohort members and other women in the community who meet the eligibility criteria. Subjects will be chosen to represent experience caring for children of different ages at the time of the nuclear tests. In order to recruit women who had children of different ages (less than 21 years) during the 1950s, we will screen potential participants for their children s years of birth and attempt to enroll women whose children represent a range of ages during the 1950 s.
- Men: In each village, we will recruit eight men (Russian and Kazakh) age 70 and older who were engaged in farming and care of dairy animals at the time of the nuclear tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Improve Thyroid Doses From Fallout Exposure in Kazakhstan
Residents of certain villages in Kazakhstan were exposed during childhood to radioactive fallout from nuclear tests conducted at the Semipalatinsk Nuclear Test Site (SNTS) between 1949 and 1962.
Radiation doses to the thyroid from external and internal (i.e., ingested) radiation sources deposited as fallout are of interest because they may be jointly and differentially associated with increased risk of thyroid disease in this population.
Read more
Objectives:
To collect information about factors influencing radiation dose to the thyroid gland in children of two ethnic groups who were exposed to radioactive fallout from nuclear tests at the SNTS between 1949 and 1962. The two groups are Kazakhs (historically nomadic herders) and Europeans (typically descendants of Russian and German farmers).
Eligibility:
Women 70 years of age and older who had children or provided care to children during the 1950s.
Men age 70 and older who were engaged in farming and care of dairy animals at the time of the nuclear tests.
Design:
In focus group format, participants are interviewed to collect information on the following at the time of nuclear tests:
- Dairy consumption;
- Source, storage and availability of milk and milk products;
- Time that children of different ages and ethnic groups spent indoors;
- Building material of houses and schools;
- Herding, grazing and supplemental feed of dairy animals.
Read the detailed description
The proposed work will improve our understanding of historical, fallout-related radiation doses received by residents of villages in Kazakhstan immediately downwind from the Semipalatinsk Nuclear Test Site (SNTS), where multiple nuclear test explosions were carried out between 1949 and 1962. In collaboration with scientists at the Institute for Biophysics in Moscow, NCI has developed a combined bi-national dose reconstruction methodology based on lessons learned from studying radioactive fallout from tests at the SNTS in Kazakhstan, the Nevada Test Site in the United States, and other test sites. Gamma rays from radionuclides such as cesium 137 in fallout are highly penetrating and can affect all organs even when the radioactive source is outside the body, whereas less-penetrating beta particles from iodine 131, also plentiful in fallout, mainly affect the thyroid gland when ingested in milk from dairy animals grazing on contaminated pasture. We are particularly interested in both kinds of radiation doses to children, because their thyroid glands are small and very active, tend to concentrate ingested iodine, and are highly sensitive to radiation carcinogenesis. The conditions of fallout exposure in Kazakhstan are directly relevant to those following a hypothetical nuclear accident or radiation terrorism incident involving high levels of local fallout.
We propose a field study in Kazakhstan to investigate aspects of typical daily village life in areas affected by fallout that might influence individual radiation doses to the thyroid gland. Using focus group interviews, we will collect retrospective information about factors influencing radiation dose to the thyroid gland in children of two distinct ethnic groups (Kazakh and European). These factors include milk and milk product consumption, dependence on different species of dairy animals known to differ with respect to concentration of iodine in milk, seasonal practices of pasturing and supplemental feeding of dairy animals at the time of the nuclear tests, time children typically spent outdoors, and radiation shielding provided by dwellings and other buildings. We will also ask about protective measures taken at the time, such as details of temporary evacuations of villages predicted to be in the fallout paths from particular tests. These data will fill key gaps in the current dose-reconstruction methodology and should result in improved dose estimates, as well as a basis for evaluating and quantifying dosimetric uncertainty and related biases in risk estimates.
- Conditions
- Thyroid Cancer, Thyroid Nodules, Other Thyroid Disease
- Keywords
- Radioactive Fallout, Childhood Exposures, External Radiation Dose, Internal Radiation Dose to Thyroid Gland, Pasture-Dairy Animal- Milk- Thyroid Pathway
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid nodules
Measured: 1998
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study start17 May 2007
- Study completion17 Aug 2017
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 Thyroid CancerStudies 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
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kiyohiko Mabuchi, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480428
- Sponsor's protocol ID
- 999907151
- Other IDs
- 07-C-N151
- Status last verified
- 17 Aug 2017
- First submitted
- 30 May 2007
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Anspaugh LR, Simon SL, Gordeev KI, Likhtarev IA, Maxwell RM, Shinkarev SM. Movement of radionuclides in terrestrial ecosystems by physical processes. Health Phys. 2002 May;82(5):669-79. doi: 10.1097/00004032-200205000-00013.
PubMed 12003017Degteva MO, Vorobiova MI, Tolstykh EI, Shagina NB, Shishkina EA, Anspaugh LR, Napier BA, Bougrov NG, Shved VA, Tokareva EE. Development of an improved dose reconstruction system for the Techa River population affected by the operation of the Mayak Production Association. Radiat Res. 2006 Jul;166(1 Pt 2):255-70. doi: 10.1667/RR3438.1.
PubMed 16808612Bogdanova TI, Zurnadzhy LY, Greenebaum E, McConnell RJ, Robbins J, Epstein OV, Olijnyk VA, Hatch M, Zablotska LB, Tronko MD. A cohort study of thyroid cancer and other thyroid diseases after the Chornobyl accident: pathology analysis of thyroid cancer cases in Ukraine detected during the first screening (1998-2000). Cancer. 2006 Dec 1;107(11):2559-66. doi: 10.1002/cncr.22321.
PubMed 17083123
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Improve Thyroid Doses From Fallout Exposure in Kazakhstan
- ClinicalTrials.gov ID
- NCT00480428
- Acronym / sponsor ID
- 999907151
- Conditions
- Thyroid Cancer, Thyroid Nodules, Other Thyroid Disease
- Keywords
- Radioactive Fallout, Childhood Exposures, External Radiation Dose, Internal Radiation Dose to Thyroid Gland, Pasture-Dairy Animal- Milk- Thyroid Pathway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 May 2007
- Study completion
- 17 Aug 2017
- First posted
- 31 May 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.
Residents of certain villages in Kazakhstan were exposed during childhood to radioactive fallout from nuclear tests conducted at the Semipalatinsk Nuclear Test Site (SNTS) between 1949 and 1962.
Radiation doses to the thyroid from external and internal (i.e., ingested) radiation sources deposited as fallout are of interest because they may be jointly and differentially associated with increased risk of thyroid disease in this population.
Objectives:
To collect information about factors influencing radiation dose to the thyroid gland in children of two ethnic groups who were exposed to radioactive fallout from nuclear tests at the SNTS between 1949 and 1962. The two groups are Kazakhs (historically nomadic herders) and Europeans (typically descendants of Russian and German farmers).
Eligibility:
Women 70 years of age and older who had children or provided care to children during the 1950s.
Men age 70 and older who were engaged in farming and care of dairy animals at the time of the nuclear tests.
Design:
In focus group format, participants are interviewed to collect information on the following at the time of nuclear tests:
- Dairy consumption;
- Source, storage and availability of milk and milk products;
- Time that children of different ages and ethnic groups spent indoors;
- Building material of houses and schools;
- Herding, grazing and supplemental feed of dairy animals.
Detailed description
The proposed work will improve our understanding of historical, fallout-related radiation doses received by residents of villages in Kazakhstan immediately downwind from the Semipalatinsk Nuclear Test Site (SNTS), where multiple nuclear test explosions were carried out between 1949 and 1962. In collaboration with scientists at the Institute for Biophysics in Moscow, NCI has developed a combined bi-national dose reconstruction methodology based on lessons learned from studying radioactive fallout from tests at the SNTS in Kazakhstan, the Nevada Test Site in the United States, and other test sites. Gamma rays from radionuclides such as cesium 137 in fallout are highly penetrating and can affect all organs even when the radioactive source is outside the body, whereas less-penetrating beta particles from iodine 131, also plentiful in fallout, mainly affect the thyroid gland when ingested in milk from dairy animals grazing on contaminated pasture. We are particularly interested in both kinds of radiation doses to children, because their thyroid glands are small and very active, tend to concentrate ingested iodine, and are highly sensitive to radiation carcinogenesis. The conditions of fallout exposure in Kazakhstan are directly relevant to those following a hypothetical nuclear accident or radiation terrorism incident involving high levels of local fallout.
We propose a field study in Kazakhstan to investigate aspects of typical daily village life in areas affected by fallout that might influence individual radiation doses to the thyroid gland. Using focus group interviews, we will collect retrospective information about factors influencing radiation dose to the thyroid gland in children of two distinct ethnic groups (Kazakh and European). These factors include milk and milk product consumption, dependence on different species of dairy animals known to differ with respect to concentration of iodine in milk, seasonal practices of pasturing and supplemental feeding of dairy animals at the time of the nuclear tests, time children typically spent outdoors, and radiation shielding provided by dwellings and other buildings. We will also ask about protective measures taken at the time, such as details of temporary evacuations of villages predicted to be in the fallout paths from particular tests. These data will fill key gaps in the current dose-reconstruction methodology and should result in improved dose estimates, as well as a basis for evaluating and quantifying dosimetric uncertainty and related biases in risk estimates.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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
Thyroid nodules
Time frame: 1998
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 16 Dec 2019.
- Background: PubMed 12003017Anspaugh LR, Simon SL, Gordeev KI, Likhtarev IA, Maxwell RM, Shinkarev SM. Movement of radionuclides in terrestrial ecosystems by physical processes. Health Phys. 2002 May;82(5):669-79. doi: 10.1097/00004032-200205000-00013.
- Background: PubMed 16808612Degteva MO, Vorobiova MI, Tolstykh EI, Shagina NB, Shishkina EA, Anspaugh LR, Napier BA, Bougrov NG, Shved VA, Tokareva EE. Development of an improved dose reconstruction system for the Techa River population affected by the operation of the Mayak Production Association. Radiat Res. 2006 Jul;166(1 Pt 2):255-70. doi: 10.1667/RR3438.1.
- Background: PubMed 17083123Bogdanova TI, Zurnadzhy LY, Greenebaum E, McConnell RJ, Robbins J, Epstein OV, Olijnyk VA, Hatch M, Zablotska LB, Tronko MD. A cohort study of thyroid cancer and other thyroid diseases after the Chornobyl accident: pathology analysis of thyroid cancer cases in Ukraine detected during the first screening (1998-2000). Cancer. 2006 Dec 1;107(11):2559-66. doi: 10.1002/cncr.22321.
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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 Thyroid Cancer and Thyroid Nodules, run by National Cancer Institute (NCI) at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 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 Kazakhstan. 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?
Thyroid nodules (time frame: 1998). 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 NCT00480428, 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 16 Dec 2019.