Thyroid CancerNCT00341094
Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Disease in Ukraine Following the Chernobyl Accident
An observational study of Thyroid Cancer and Non-Cancer Thyroid Disease, run by National Cancer Institute (NCI) at 1 site in Ukraine.
Trial summary
The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine in the atmosphere, contaminating thousands of square kilometers and exposing millions of people. Read more about this study
- Who is it for?
- Ages 18 to 48 years
- Conditions the study is for
- Thyroid Cancer, Non-Cancer Thyroid Disease, Non Thyroid Cancer
- How many people
- 23,143 participants
- Where
- 1 siteUkraine
- Study dates
- 1 May 1995to 8 Oct 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 48 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects exposed to I131 before the age of 18 years and subjects exposed to I131 in utero
Who may be able to join
- Sample selection in Belarus consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.
- Sample selection in Ukraine consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.
- Sample from Ukraine lived at least part of the time between 26 April and 30 June 1986 in the town of Pripyat or in one of the 8 most contaminated raions (Ivankivskyi, Chornobylskyi, and Poliskyi raiions in the Kyiv Oblast; Narodychskyi and Ovruchskyi in Zhitomyr Oblast; Repkinsky. Kozeletskyi, and Chernihivskyi in Chernihiv Oblast).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Research Institute of Endocrinology and Metabolism, Kiev, Ukraine
Kiev
About this study
Official title: Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident
The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine in the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Ukrainian children aged 0-18 years or in utero at the time of the accident are being identified and examined by well-trained specialists for thyroid disease every two years for at least three cycles. The study is a collaborative effort of research in Ukraine and the United States.
The cohort will include approximately 13,000 persons who were children in 1986, all or most of whom have had their thyroids measured for radioactivity during the weeks immediately following the accident (or whose mothers had measurements taken while the child was in utero). Under a rigid research protocol these subjects will receive diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests, and, if indicated, fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history will also be collected. All subjects will be followed for thyroid cancer morbidity and mortality. Thyroid cancers will be confirmed by expert pathology examination of tissue.
Read more
In addition to the analysis of thyroid radiation measurements made in May-June, 1986, efforts will be made to reconstruct each person's exposure and to estimate the radiation dose to the thyroid. This will involve the reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period.
The aim of the study is to carry out valid and credible assessments of the early and late morphologic and functional changes in the thyroid glands of persons exposed to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident. The emphasis is on dose- and time-specific changes.
In the course of the study other possible risk factors will be examined including dietary iodine intake during and after 1986, and the ingestion of potassium iodide for thyroid protection shortly after the accident.
Read the detailed description
The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Ukrainian children aged less than 18 years or in utero at the time of the accident were identified and have been followed up. The main cohort was screened for thyroid disease every two years for 4 cycles from 1998 through 2007, with another cycle resumed in 2011(fifth cycle), which is now underway. The in utero cohort was screened between 2003-2006 and has also been screened since 2011. The study is a collaborative effort of researchers in Ukraine and the United States.
The main cohort includes approximately 13,000 persons who were children in 1986, all or most of whom had their thyroids measured for radioactivity during the weeks immediately following the accident. Under a rigid research protocol, these subjects receive diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests (only in the first four cycles). If indicated, they are referred for a fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history has also been collected. All subjects are followed for thyroid cancer morbidity. Thyroid cancers are confirmed by expert pathology examination of tissue obtained during surgery. The in utero cohort includes a total of 2,582 individuals. In addition starting in 2003, ~ 7,000 parents of members of the main cohort who were under age 10 y at the time of the accident were interviewed in order to increase the accuracy of recall. These individuals were listed as new subjects. Altogether, 23,143 individuals have been accrued in this study.
In addition to the analysis of thyroid radiation measurements made in May-June, 1986, radiation dose to the thyroid was estimated drawing on such data as the reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period. For in utero subjects, fetal dose has been estimated based on the mother s thyroid dose.
The aim of the study is to assess the early and late morphologic and functional changes in the thyroid glands of persons exposed at young ages to radiation from radioactive materials released as a consequence of the Chernobyl nuclear power plant accident, with emphasis on dose-and time-specific changes.
There have been several amendments to the protocol: transition in 2008 to cancer case ascertainment using a passive form of follow-up based on linkage to the National Cancer Registry of Ukraine (NCRU) which still continues during thefifth cycle of screening; a sub-study involving an additional follow-up examination of those cohort members who were diagnosed with benign nodular thyroid pathology during one of the earlier four active screening cycles; and genetic studies (gene expression and germline SNP studies) of thyroid cancer in this Ukrainian cohort exposed to radioiodines from Chernobyl fallout as children or adolescents; and most recently, a pilot study of genomic characterization of thyroid cancers (2013).
- Keywords
- Cohort, Radiation, In Utero, Genomic
- 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 |
|---|---|---|
| Main UkrArm | Subjects exposed to I131 before the age of 18 years | |
| Ukraine in utero | Subjects exposed to I131 in utero |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation related risk of benign and malignant thyroid disease
Radiation risk
Measured: 2-3 years after initiation of study
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 start1 May 1995
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23,143 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elizabeth K Cahoon, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341094
- Sponsor's protocol ID
- 999995020
- Other IDs
- OH95-C-N020
- Status last verified
- Oct 2020
- First submitted
- 19 Jun 2006
- Last updated
- 9 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Protocol for the Study of Thyroid Cancer and Other Thyroid Diseases in Ukraine Following the Chernobyl Accident
- ClinicalTrials.gov ID
- NCT00341094
- Acronym / sponsor ID
- 999995020
- Keywords
- Cohort, Radiation, In Utero, Genomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,143 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 May 1995 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- 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.
The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine in the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Ukrainian children aged 0-18 years or in utero at the time of the accident are being identified and examined by well-trained specialists for thyroid disease every two years for at least three cycles. The study is a collaborative effort of research in Ukraine and the United States.
The cohort will include approximately 13,000 persons who were children in 1986, all or most of whom have had their thyroids measured for radioactivity during the weeks immediately following the accident (or whose mothers had measurements taken while the child was in utero). Under a rigid research protocol these subjects will receive diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests, and, if indicated, fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history will also be collected. All subjects will be followed for thyroid cancer morbidity and mortality. Thyroid cancers will be confirmed by expert pathology examination of tissue.
In addition to the analysis of thyroid radiation measurements made in May-June, 1986, efforts will be made to reconstruct each person's exposure and to estimate the radiation dose to the thyroid. This will involve the reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period.
The aim of the study is to carry out valid and credible assessments of the early and late morphologic and functional changes in the thyroid glands of persons exposed to radiation from radioactive materials released as a consequence of the Chornobyl nuclear power plant accident. The emphasis is on dose- and time-specific changes.
In the course of the study other possible risk factors will be examined including dietary iodine intake during and after 1986, and the ingestion of potassium iodide for thyroid protection shortly after the accident.
Detailed description
The nuclear power plant accident at Chornobyl released large quantities of Iodine-131 and other radioisotopes of iodine into the atmosphere, contaminating thousands of square kilometers and exposing millions of people. For this study, a well-defined subset of Ukrainian children aged less than 18 years or in utero at the time of the accident were identified and have been followed up. The main cohort was screened for thyroid disease every two years for 4 cycles from 1998 through 2007, with another cycle resumed in 2011(fifth cycle), which is now underway. The in utero cohort was screened between 2003-2006 and has also been screened since 2011. The study is a collaborative effort of researchers in Ukraine and the United States.
The main cohort includes approximately 13,000 persons who were children in 1986, all or most of whom had their thyroids measured for radioactivity during the weeks immediately following the accident. Under a rigid research protocol, these subjects receive diagnostic thyroid examinations, including palpation, ultrasound scanning, thyroid hormone and other laboratory tests (only in the first four cycles). If indicated, they are referred for a fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history has also been collected. All subjects are followed for thyroid cancer morbidity. Thyroid cancers are confirmed by expert pathology examination of tissue obtained during surgery. The in utero cohort includes a total of 2,582 individuals. In addition starting in 2003, ~ 7,000 parents of members of the main cohort who were under age 10 y at the time of the accident were interviewed in order to increase the accuracy of recall. These individuals were listed as new subjects. Altogether, 23,143 individuals have been accrued in this study.
In addition to the analysis of thyroid radiation measurements made in May-June, 1986, radiation dose to the thyroid was estimated drawing on such data as the reconstruction of deposition patterns and environmental pathways of the radioiodines, and of the location, dietary characteristics, and lifestyle of each person throughout the exposure period. For in utero subjects, fetal dose has been estimated based on the mother s thyroid dose.
The aim of the study is to assess the early and late morphologic and functional changes in the thyroid glands of persons exposed at young ages to radiation from radioactive materials released as a consequence of the Chernobyl nuclear power plant accident, with emphasis on dose-and time-specific changes.
There have been several amendments to the protocol: transition in 2008 to cancer case ascertainment using a passive form of follow-up based on linkage to the National Cancer Registry of Ukraine (NCRU) which still continues during thefifth cycle of screening; a sub-study involving an additional follow-up examination of those cohort members who were diagnosed with benign nodular thyroid pathology during one of the earlier four active screening cycles; and genetic studies (gene expression and germline SNP studies) of thyroid cancer in this Ukrainian cohort exposed to radioiodines from Chernobyl fallout as children or adolescents; and most recently, a pilot study of genomic characterization of thyroid cancers (2013).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main UkrArm | – | –Subjects exposed to I131 before the age of 18 years |
| Ukraine in utero | – | –Subjects exposed to I131 in utero |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects exposed to I131 before the age of 18 years and subjects exposed to I131 in utero
Key inclusion criteria (3 listed)
- Sample selection in Belarus consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.
- Sample selection in Ukraine consists of all children who were born between 26 April 1968 and 26 April 1986 and had their thyroid radio-activity measured in 1986 shortly after the accident.
- Sample from Ukraine lived at least part of the time between 26 April and 30 June 1986 in the town of Pripyat or in one of the 8 most contaminated raions (Ivankivskyi, Chornobylskyi, and Poliskyi raiions in the Kyiv Oblast; Narodychskyi and Ovruchskyi in Zhitomyr Oblast; Repkinsky. Kozeletskyi, and Chernihivskyi in Chernihiv Oblast).
Key exclusion criteria (0 listed)
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
Radiation related risk of benign and malignant thyroid disease
Time frame: 2-3 years after initiation of study
Radiation risk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
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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.
Elizabeth K Cahoon 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 and Non-Cancer Thyroid Disease, 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 9 Oct 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiation related risk of benign and malignant thyroid disease (time frame: 2-3 years after initiation of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2020.