NCT00480428

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
10.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
Last Updated

December 16, 2019

Status Verified

August 17, 2017

First QC Date

May 30, 2007

Last Update Submit

December 13, 2019

Conditions

Keywords

Radioactive FalloutChildhood ExposuresExternal Radiation DoseInternal Radiation Dose to Thyroid GlandPasture-Dairy Animal- Milk- Thyroid Pathway

Outcome Measures

Primary Outcomes (1)

  • Thyroid nodules

    1998

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
* 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. 1. 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. 2. 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.

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

Sponsors & Collaborators

Study Sites (1)

Semipalatinsk State Medical Academy

Semipalatinsk, Kazakhstan

Location

Related Publications (3)

  • 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.

    PMID: 12003017BACKGROUND
  • Degteva 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.

    PMID: 16808612BACKGROUND
  • Bogdanova 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.

    PMID: 17083123BACKGROUND

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Kiyohiko Mabuchi, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

May 17, 2007

Study Completion

August 17, 2017

Last Updated

December 16, 2019

Record last verified: 2017-08-17

Locations