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Thyroid CancerNCT01265381

Thyroid Cancer Among Chornobyl Clean-up Workers in Ukraine: Pilot Study

An observational study of Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in Ukraine.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Background: The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of Health have been studying cancer risks and outcomes in individuals who participated in the decontamination clean-up process following the Chornobyl nuclear accident. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Thyroid Cancer
How many people
673 participants
Where
1 siteUkraine
Study dates
22 Dec 2010to 26 Feb 2020
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 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Ukrainian Chernobyl clean-up workers ("liquidators") approx. 150,000

Who may be able to join

  • For the pilot study, we will select clean-up workers with thyroid cancer reported in three study areas, Kyiv, Donetsk and Dnipropetrovsk oblasts and controls (with a case-control ratio of 1:3) demographically matched to cases. We estimate the number of these cases will be between 100 and 110. These two oblasts have been chosen to represent an area known, from the leukemia study, to have a high study participation rate (Kyiv and Dnipropetrovsk oblasts) and an area newly added and thus unknown regarding participation rate (Donetsk). All study subjects are males and average about 55 years. In view of the very high survival rate for thyroid cancer, a majority of the subjects are expected to be alive.

Who cannot join

  • Excluded from the study will be those who cannot be located, refuse to participate in the study, or do not provide informed consent.

Trial locations and contacts

1 site in 1 country.

Ukraine1 site
  • Research Center for Radiation Medicine

    Kiev

Other trials in Ukraine

About this study

Background:

  • The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of Health have been studying cancer risks and outcomes in individuals who participated in the decontamination clean-up process following the Chornobyl nuclear accident. Some of these individuals were exposed to external radiation at various levels, as well as radioactive iodine that may have affected the thyroid and increased the risk of developing thyroid cancer. Because more individual and comparative data are needed on the affected populations and clean-up workers associated with the Chornobyl accident, researchers are interested in collecting personal information and saliva samples from Chornobyl clean-up workers who have been diagnosed with thyroid cancer.
Read more

Objectives:

  • To assess the radiation-related risk of thyroid cancer among male Chornobyl clean-up workers and collect saliva samples for an initial study.

Eligibility:

  • Male Chornobyl clean-up workers from Kyiv and Donetsk oblasts who have been diagnosed with thyroid cancer.

Design:

  • Participants will complete a standardized questionnaire during a personal interview. The questionnaire will ask for detailed information on the following areas of study:
  • Work history, conditions, and activities inside the 70-km clean-up and radiation calculation zone.
  • Residence history inside and outside the 30-km exclusion zone.
  • Milk consumption between April 26 and June 30, 1986 (to assess radioactivity from radioiodine fallout).
  • Potential non-radiation risk factors for thyroid cancer (e.g., smoking, alcohol consumption, family cancer history).
  • Participants will provide a saliva sample for pilot study testing....
Read the detailed description

Background:

Much is known about the radiation-related risk of thyroid cancer, but there is considerable uncertainty about the magnitude of the radiation risk among those who were exposed as adults, particularly in males. A large number of clean-up workers, mostly male, who participated in decontamination and clean-up activities after the Chornobyl accident were exposed to external radiation at various levels. An increased thyroid cancer risk has been reported from studies of Russian, Estonian and Latvian clean-up workers, but there is little evidence of a dose response. However, recent published data from an IARC study of thyroid cancer cases and controls pooled from the Chornobyl clean-up workers in Belarus, Russia and Baltic countries show a strong dose response with an estimated risk per unit dose that is much higher than those reported from other irradiated populations exposed as adults. Following the completion of our NCI study of leukemia among Ukrainian clean-up workers, we are proposing a nested case-control study to assess the radiation-related risk of thyroid cancer among the 150,000 male cleanup workers in Ukraine. In preparation for this study, a pilot study is in progress to assess the feasibility of a full study.

Objectives:

The objectives are (i) to identify thyroid cancer cases and demographically matched controls without thyroid cancer occurring among the 150,000 Ukrainian clean-up workers through linkage to the National Cancer Registry and Chernobyl State Registry of Ukraine; (ii) to trace/locate and interview a small sample of subjects with thyroid cancer and their respective controls ; (iii) to obtain saliva buccal cell samples; and (iv) to locate and transfer thyroid tumor specimens from identified cases to the archive maintained at the Research Center for Radiation Medicine (RCRM),for diagnostic verification and possible future genetic/molecular research using the latest available techniques.

Eligibility:

The cohort includes Ukrainian clean-up workers who meet the following eligibility criteria: males, first year of service as a clean-up worker (1986-1990); initial registration as a clean-up worker in one of the study areas; and age when first worked in the Chornobyl zone (under 60). For the pilot study, we will select 100-110 cases with thyroid cancer in three study areas, Kyiv, Donetsk and Dnipropetrovsk oblasts and controls (with a case-control ratio of 1:3). We will assess the feasibility of proxy interview for deceased thyroid cancer cases in the study area.

Design:

This pilot study will be conducted in the framework of the planned nested case-control study in the cohort of Chornobyl clean-up workers but will involve only a small number of subjects with thyroid cancer and their respective controls. Thyroid cancer cases will be identified by linkage to the Cancer Registry of Ukraine. Controls will be identified from the Chernobyl State Registry. Locating archived tumor tissues will be done by search of the Cancer Registry of Ukraine database supplemented by interview data. Consent for transfer of tissues to RCRM will be sought at the time of interview.

Conditions
Thyroid Cancer
Keywords
Cohort, Radiation, Thyroid Cancer
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01265381
Study groupRoleWhat they receive
Cohort of Chernobyl Cleanup Workers in UkraineThyroid cancer cases and matched controls in the cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the radiation - related risk of thyroid cancer among the 150,000 male clean-up workers in Ukraine

    Risk of thyroid cancer attributable to radiation

    Measured: At time of analysis completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2010 (estimated)
  2. Study start22 Dec 2010
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

Why it stopped: This protocol was determined to be not human subjects research.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01265381
Sponsor's protocol ID
999911049
Other IDs
11-C-N049
Status last verified
Mar 2019
First submitted
22 Dec 2010
Last updated
3 Mar 2020
Results posted
No

Publications

  • Mabuchi K, Hatch M, Little MP, Linet MS, Simon SL. Risk of thyroid cancer after adult radiation exposure: time to re-assess? Radiat Res. 2013 Feb;179(2):254-6. doi: 10.1667/RR3121.1. Epub 2012 Dec 19.

    PubMed 23252377
  • Ostroumova E, Gudzenko N, Brenner A, Gorokh Y, Hatch M, Prysyazhnyuk A, Mabuchi K, Bazyka D. Thyroid cancer incidence in Chornobyl liquidators in Ukraine: SIR analysis, 1986-2010. Eur J Epidemiol. 2014 May;29(5):337-42. doi: 10.1007/s10654-014-9896-1. Epub 2014 Apr 5.

    PubMed 24705729
  • Kesminiene A, Evrard AS, Ivanov VK, Malakhova IV, Kurtinaitise J, Stengrevics A, Tekkel M, Chekin S, Drozdovitch V, Gavrilin Y, Golovanov I, Kryuchkov VP, Maceika E, Mirkhaidarov AK, Polyakov S, Tenet V, Tukov AR, Byrnes G, Cardis E. Risk of thyroid cancer among chernobyl liquidators. Radiat Res. 2012 Nov;178(5):425-36. doi: 10.1667/RR2975.1. Epub 2012 Sep 21.

    PubMed 22998226

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Cancer, run by National Cancer Institute (NCI) at 1 site in Ukraine.

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 1 inclusion and 1 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 3 Mar 2020. 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 Ukraine. 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 (reason given: This protocol was determined to be not human subjects research.). 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.

What does the primary outcome measure?

To assess the radiation - related risk of thyroid cancer among the 150,000 male clean-up workers in Ukraine (time frame: At time of analysis completion). 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 NCT01265381, 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 3 Mar 2020.

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