Thyroid AbnormalitiesNCT00342693
Thyroid Abnormalities Associated With Exposure to Atmospheric Emissions of Radioactive Iodine
An observational study of Thyroid Abnormalities, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: An inadequate filtering system at the Mayak nuclear weapons production facility in Ozyorsk, Russia, allowed the release of various radioactive materials, particularly I-131 (radioactive iodine) into the city's atmosphere during the 1950s. Read more about this study
- Who is it for?
- Ages 51 to 52 years
- Conditions the study is for
- Thyroid Abnormalities
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2006to 3 Sep 2013
- 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 51 to 52 years
- All sexes
- No healthy volunteers
- Adult
- Eligibility Criteria:
Currently living and working in Ozyorsk, Russian Federation
Born and living in Ozyorsk between January 1954 and December 1955
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Thyroid Abnormalities Associated With Protracted Childhood I-131 Exposure From Atmospheric Emissions From the Mayak Nuclear Plant in Russia
Background:
- An inadequate filtering system at the Mayak nuclear weapons production facility in Ozyorsk, Russia, allowed the release of various radioactive materials, particularly I-131 (radioactive iodine) into the city's atmosphere during the 1950s.
- A recent pilot study found a higher prevalence of thyroid nodules in Ozyorsk residents who were exposed to the radiation in childhood during years of heavy atmospheric emissions (1952-1953) than in children exposed in later years (between 1967 and 1991) when there were almost no radioactive releases.
- Understanding the role of I-131 in the development of thyroid disease is important because I-131 is commonly used in medicine (e.g., to treat hyperthyroidism and thyroid cancer and to diagnose thyroid disease), and it is the major source of thyroid gland exposure in fallout from atomic bomb explosions, nuclear power plant accidents, and atmospheric venting from plutonium manufacturing facilities.
Read more
Objectives:
-To expand the pilot study to include 350 Ozyorsk residents who were exposed in childhood to moderate levels of radiation in order to evaluate thyroid disease in relation to the dose of I-131 exposure.
Eligibility:
-People who were born and living in Ozyorsk, Russia between 1954 and 1955, the period of mild radioactive releases from the Mayak nuclear weapons plant.
Design:
- Participants' thyroid gland and structure are examined with an ultrasound examination and blood tests.
- Participants with a possible thyroid gland disorder are referred to specialists for additional diagnostic procedures.
Read the detailed description
We plan to expand a completed pilot study that evaluated the prevalence of thyroid abnormalities in relation to childhood exposure to atmospheric emissions of radioactive iodines from the Mayak Nuclear Weapons Plant in Ozyorsk, Russia. The pilot study population was composed of a defined cohort of approximately 900 Ozyorsk residents who were born between January 1, 1952 and December 31, 1953. The exposed population was comprised of persons who lived in Ozyorsk during the years of heavy atmospheric releases (1952-1953). Members of the nonexposed group moved to Ozyorsk between 1967 and 1991, i.e. when there were almost no radioactive releases. Results from the pilot study suggest an elevated prevalence of thyroid nodules in the exposed population. Given the positive results from the pilot study and the US Department of Energy's (DOE) decision to fund a dose reconstruction project for the Ozyorsk population, we intend to expand the study to include an additional 350 people born and living in Ozyorsk between 1954 and 1955, i.e. exposed to moderate levels of radiation .
Methods similar to those used in the pilot study will be used in the expanded study. Members of the study population will be invited to participate in a special thyroid screening protocol when they come for their annual routine medical examination at the Ozyorsk automated dispensary system (ASDOC). The thyroid gland is clinically examined by two ASDOC physicians specifically trained in thyroid palpation. Thyroid abnormalities will be detected based on physical examinations, assessment of TSH levels, and ultrasound imaging. Biochemical laboratory tests, including Free T(4), and anti-thyroperoxidase antibodies will be assayed as necessary. Patients are sent to a consulting endocrinologist if the palpation, ultrasound or laboratory findings suggest a thyroid disorder. Fine needle aspiration (FNA) biopsy is performed when a tumor is suspected. Although the FNA is not be done as part of the study research, but rather as part of the regular Ozyorsk medical system, the results will be given to the study staff to help make diagnostic decisions. Patients with complicated thyroid disease will be referred to an experienced consulting thyroid specialist. Patients with diagnosed thyroid disease are treated within the regular medical system in Ozyorsk.
- Conditions
- Thyroid Abnormalities
- Keywords
- Radiation, Screening, Cancer, Nodules, Nuclear, Thyroid Screening, Thyroid Gland
- Medical subject headings
- Thyroid Diseases, Neoplasms
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 start21 Feb 2006
- Study completion3 Sep 2013
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 AbnormalitiesStudies 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
- 360 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
- NCT00342693
- Sponsor's protocol ID
- 999906103
- Other IDs
- 06-C-N103
- Status last verified
- 3 Sep 2013
- First submitted
- 19 Jun 2006
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Astakhova LN, Anspaugh LR, Beebe GW, Bouville A, Drozdovitch VV, Garber V, Gavrilin YI, Khrouch VT, Kuvshinnikov AV, Kuzmenkov YN, Minenko VP, Moschik KV, Nalivko AS, Robbins J, Shemiakina EV, Shinkarev S, Tochitskaya SI, Waclawiw MA. Chernobyl-related thyroid cancer in children of Belarus: a case-control study. Radiat Res. 1998 Sep;150(3):349-56.
PubMed 9728663Cardis E, Kesminiene A, Ivanov V, Malakhova I, Shibata Y, Khrouch V, Drozdovitch V, Maceika E, Zvonova I, Vlassov O, Bouville A, Goulko G, Hoshi M, Abrosimov A, Anoshko J, Astakhova L, Chekin S, Demidchik E, Galanti R, Ito M, Korobova E, Lushnikov E, Maksioutov M, Masyakin V, Nerovnia A, Parshin V, Parshkov E, Piliptsevich N, Pinchera A, Polyakov S, Shabeka N, Suonio E, Tenet V, Tsyb A, Yamashita S, Williams D. Risk of thyroid cancer after exposure to 131I in childhood. J Natl Cancer Inst. 2005 May 18;97(10):724-32. doi: 10.1093/jnci/dji129.
PubMed 15900042Davis S, Stepanenko V, Rivkind N, Kopecky KJ, Voilleque P, Shakhtarin V, Parshkov E, Kulikov S, Lushnikov E, Abrosimov A, Troshin V, Romanova G, Doroschenko V, Proshin A, Tsyb A. Risk of thyroid cancer in the Bryansk Oblast of the Russian Federation after the Chernobyl Power Station accident. Radiat Res. 2004 Sep;162(3):241-8. doi: 10.1667/rr3233.
PubMed 15332999
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Abnormalities Associated With Protracted Childhood I-131 Exposure From Atmospheric Emissions From the Mayak Nuclear Plant in Russia
- ClinicalTrials.gov ID
- NCT00342693
- Acronym / sponsor ID
- 999906103
- Conditions
- Thyroid Abnormalities
- Keywords
- Radiation, Screening, Cancer, Nodules, Nuclear, Thyroid Screening, Thyroid Gland
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 360 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Feb 2006
- Study completion
- 3 Sep 2013
- 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.
Background:
- An inadequate filtering system at the Mayak nuclear weapons production facility in Ozyorsk, Russia, allowed the release of various radioactive materials, particularly I-131 (radioactive iodine) into the city's atmosphere during the 1950s.
- A recent pilot study found a higher prevalence of thyroid nodules in Ozyorsk residents who were exposed to the radiation in childhood during years of heavy atmospheric emissions (1952-1953) than in children exposed in later years (between 1967 and 1991) when there were almost no radioactive releases.
- Understanding the role of I-131 in the development of thyroid disease is important because I-131 is commonly used in medicine (e.g., to treat hyperthyroidism and thyroid cancer and to diagnose thyroid disease), and it is the major source of thyroid gland exposure in fallout from atomic bomb explosions, nuclear power plant accidents, and atmospheric venting from plutonium manufacturing facilities.
Objectives:
-To expand the pilot study to include 350 Ozyorsk residents who were exposed in childhood to moderate levels of radiation in order to evaluate thyroid disease in relation to the dose of I-131 exposure.
Eligibility:
-People who were born and living in Ozyorsk, Russia between 1954 and 1955, the period of mild radioactive releases from the Mayak nuclear weapons plant.
Design:
- Participants' thyroid gland and structure are examined with an ultrasound examination and blood tests.
- Participants with a possible thyroid gland disorder are referred to specialists for additional diagnostic procedures.
Detailed description
We plan to expand a completed pilot study that evaluated the prevalence of thyroid abnormalities in relation to childhood exposure to atmospheric emissions of radioactive iodines from the Mayak Nuclear Weapons Plant in Ozyorsk, Russia. The pilot study population was composed of a defined cohort of approximately 900 Ozyorsk residents who were born between January 1, 1952 and December 31, 1953. The exposed population was comprised of persons who lived in Ozyorsk during the years of heavy atmospheric releases (1952-1953). Members of the nonexposed group moved to Ozyorsk between 1967 and 1991, i.e. when there were almost no radioactive releases. Results from the pilot study suggest an elevated prevalence of thyroid nodules in the exposed population. Given the positive results from the pilot study and the US Department of Energy's (DOE) decision to fund a dose reconstruction project for the Ozyorsk population, we intend to expand the study to include an additional 350 people born and living in Ozyorsk between 1954 and 1955, i.e. exposed to moderate levels of radiation .
Methods similar to those used in the pilot study will be used in the expanded study. Members of the study population will be invited to participate in a special thyroid screening protocol when they come for their annual routine medical examination at the Ozyorsk automated dispensary system (ASDOC). The thyroid gland is clinically examined by two ASDOC physicians specifically trained in thyroid palpation. Thyroid abnormalities will be detected based on physical examinations, assessment of TSH levels, and ultrasound imaging. Biochemical laboratory tests, including Free T(4), and anti-thyroperoxidase antibodies will be assayed as necessary. Patients are sent to a consulting endocrinologist if the palpation, ultrasound or laboratory findings suggest a thyroid disorder. Fine needle aspiration (FNA) biopsy is performed when a tumor is suspected. Although the FNA is not be done as part of the study research, but rather as part of the regular Ozyorsk medical system, the results will be given to the study staff to help make diagnostic decisions. Patients with complicated thyroid disease will be referred to an experienced consulting thyroid specialist. Patients with diagnosed thyroid disease are treated within the regular medical system in Ozyorsk.
Study design
Who may qualify
- Ages
- 51 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
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 5 Apr 2018.
- Background: PubMed 9728663Astakhova LN, Anspaugh LR, Beebe GW, Bouville A, Drozdovitch VV, Garber V, Gavrilin YI, Khrouch VT, Kuvshinnikov AV, Kuzmenkov YN, Minenko VP, Moschik KV, Nalivko AS, Robbins J, Shemiakina EV, Shinkarev S, Tochitskaya SI, Waclawiw MA. Chernobyl-related thyroid cancer in children of Belarus: a case-control study. Radiat Res. 1998 Sep;150(3):349-56.
- Background: PubMed 15900042Cardis E, Kesminiene A, Ivanov V, Malakhova I, Shibata Y, Khrouch V, Drozdovitch V, Maceika E, Zvonova I, Vlassov O, Bouville A, Goulko G, Hoshi M, Abrosimov A, Anoshko J, Astakhova L, Chekin S, Demidchik E, Galanti R, Ito M, Korobova E, Lushnikov E, Maksioutov M, Masyakin V, Nerovnia A, Parshin V, Parshkov E, Piliptsevich N, Pinchera A, Polyakov S, Shabeka N, Suonio E, Tenet V, Tsyb A, Yamashita S, Williams D. Risk of thyroid cancer after exposure to 131I in childhood. J Natl Cancer Inst. 2005 May 18;97(10):724-32. doi: 10.1093/jnci/dji129.
- Background: PubMed 15332999Davis S, Stepanenko V, Rivkind N, Kopecky KJ, Voilleque P, Shakhtarin V, Parshkov E, Kulikov S, Lushnikov E, Abrosimov A, Troshin V, Romanova G, Doroschenko V, Proshin A, Tsyb A. Risk of thyroid cancer in the Bryansk Oblast of the Russian Federation after the Chernobyl Power Station accident. Radiat Res. 2004 Sep;162(3):241-8. doi: 10.1667/rr3233.
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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 Thyroid Abnormalities, run by National Cancer Institute (NCI) at 1 site in United States.
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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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 United States. 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 NCT00342693, 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 5 Apr 2018.