NCT00342693

Brief 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.
  • 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2013

Completed
Last Updated

April 5, 2018

Status Verified

September 3, 2013

First QC Date

June 19, 2006

Last Update Submit

April 4, 2018

Conditions

Thyroid Abnormalities

Keywords

RadiationScreeningCancerNodulesNuclearThyroid ScreeningThyroid Gland

Eligibility Criteria

Age51 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
* Eligibility Criteria: Currently living and working in Ozyorsk, Russian Federation Born and living in Ozyorsk between January 1954 and December 1955

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 9728663BACKGROUND

  • Cardis 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.

    PMID: 15900042BACKGROUND

  • Davis 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.

    PMID: 15332999BACKGROUND

MeSH Terms

Conditions

Thyroid DiseasesNeoplasms

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Martha Linet, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

February 21, 2006

Study Completion

September 3, 2013

Last Updated

April 5, 2018

Record last verified: 2013-09-03

Locations

US(1)