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.
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.
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 group | Role | What they receive |
|---|---|---|
| Cohort of Chernobyl Cleanup Workers in Ukraine | Thyroid 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.
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.
- First posted23 Dec 2010 (estimated)
- Study start22 Dec 2010
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Why it stopped: This protocol was determined to be not human subjects research.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 673 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
- 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 23252377Ostroumova 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 24705729Kesminiene 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Cancer Among Chornobyl Clean-up Workers in Ukraine: Pilot Study
- ClinicalTrials.gov ID
- NCT01265381
- Acronym / sponsor ID
- 999911049
- Conditions
- Thyroid Cancer
- Keywords
- Cohort, Radiation, Thyroid Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This protocol was determined to be not human subjects research.
- Enrolment
- 673 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 Dec 2010 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 23 Dec 2010 (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:
- 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.
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....
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of Chernobyl Cleanup Workers in Ukraine | – | –Thyroid cancer cases and matched controls in the cohort |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ukrainian Chernobyl clean-up workers ("liquidators") approx. 150,000
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Excluded from the study will be those who cannot be located, refuse to participate in the study, or do not provide informed consent.
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
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
Risk of thyroid cancer attributable to radiation
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 23252377Mabuchi 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.
- Background: PubMed 24705729Ostroumova 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.
- Background: PubMed 22998226Kesminiene 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.
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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, 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.