EnvironmentNCT00339274
International Cooperation for Post-Cherynobyl NIS Thyroid Tissue and Data Banks
An observational study of Environment, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
The large number of thyroid tumors that have occurred in areas exposed to high levels of fallout from the Chernobyl accident raise problems of public health importance, or regulatory importance, and of scientific importance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Environment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 1999to 16 Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with thyroid tumours from the whole of Belarus, and the contaminated oblasts of the Russian Federation and Ukraine who were born after 26th April 1967.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Chernobyl Tissue Bank
The large number of thyroid tumors that have occurred in areas exposed to high levels of fallout from the Chernobyl accident raise problems of public health importance, or regulatory importance, and of scientific importance. The over-riding priority must go to matters such as diagnosis, treatment of those affected and prevention, and International Agencies are giving financial and material help in these areas. However providing the needs of the patient are not compromised, it is very important to ensure that information that may be of value to the health of future generations is not lost. International agencies are again providing financial support for a variety of joint studies, some of which are based on studies of tissues from thyroid operations carried out as part of treatment, and not required for the initial diagnosis on which treatment is based. An international coordinated approach to this problem is not in place to help Belarus, the Russian Federation and Ukraine to establish their own comprehensive thyroid tissue and data banks and to ensure that tissue and nucleic acids are used to contribute to the understanding of the consequences of the Chernobyl accident. This project has the support of the Governments of Belarus, the Russian Federation and Ukraine and the National Cancer Institute of the USA, (NCI), the European Commission (EC), the Sasakawa Memorial Health Foundation of Japan (SMHF) and the World Health Organization (WHO) have agreed to cooperate in supporting this project.
Read the detailed description
The large number of thyroid tumors that have occurred in areas exposed to high levels of fallout from the Chernobyl accident raise problems of public health importance, or regulatory importance, and of scientific importance. The over-riding priority must go to matters such as diagnosis, treatment of those affected and prevention, and International Agencies are giving financial and material help in these areas. However providing the needs of the patient are not compromised, it is very important to ensure that information that may be of value to the health of future generations is not lost. International agencies are again providing financial support for a variety of joint studies, some of which are based on studies of tissues from thyroid operations carried out as part of treatment, and not required for the initial diagnosis on which treatment is based. An international coordinated approach to this problem is not in place to help Belarus, the Russian Federation and Ukraine to establish their own comprehensive thyroid tissue and data banks and to ensure that tissue and nucleic acids are used to contribute to the understanding of the consequences of the Chernobyl accident. This project has the support of the Governments of Belarus, the Russian Federation and Ukraine and the National Cancer Institute of the USA, (NCI), the European Commission (EC), the Sasakawa Memorial Health Foundation of Japan (SMHF) and the World Health Organization (WHO) have agreed to cooperate in supporting this project.
- Conditions
- Environment
- Keywords
- Repositories, Pathology, Belarus, Russia, Ukraine
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 start14 Oct 1999
- Study completion16 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnvironmentStudies 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
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Louise Brinton, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339274
- Sponsor's protocol ID
- 999900024
- Other IDs
- OH00-C-N024
- Status last verified
- 16 Mar 2012
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chernobyl Tissue Bank
- ClinicalTrials.gov ID
- NCT00339274
- Acronym / sponsor ID
- 999900024
- Conditions
- Environment
- Keywords
- Repositories, Pathology, Belarus, Russia, Ukraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Oct 1999
- Study completion
- 16 Mar 2012
- 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 large number of thyroid tumors that have occurred in areas exposed to high levels of fallout from the Chernobyl accident raise problems of public health importance, or regulatory importance, and of scientific importance. The over-riding priority must go to matters such as diagnosis, treatment of those affected and prevention, and International Agencies are giving financial and material help in these areas. However providing the needs of the patient are not compromised, it is very important to ensure that information that may be of value to the health of future generations is not lost. International agencies are again providing financial support for a variety of joint studies, some of which are based on studies of tissues from thyroid operations carried out as part of treatment, and not required for the initial diagnosis on which treatment is based. An international coordinated approach to this problem is not in place to help Belarus, the Russian Federation and Ukraine to establish their own comprehensive thyroid tissue and data banks and to ensure that tissue and nucleic acids are used to contribute to the understanding of the consequences of the Chernobyl accident. This project has the support of the Governments of Belarus, the Russian Federation and Ukraine and the National Cancer Institute of the USA, (NCI), the European Commission (EC), the Sasakawa Memorial Health Foundation of Japan (SMHF) and the World Health Organization (WHO) have agreed to cooperate in supporting this project.
Detailed description
The large number of thyroid tumors that have occurred in areas exposed to high levels of fallout from the Chernobyl accident raise problems of public health importance, or regulatory importance, and of scientific importance. The over-riding priority must go to matters such as diagnosis, treatment of those affected and prevention, and International Agencies are giving financial and material help in these areas. However providing the needs of the patient are not compromised, it is very important to ensure that information that may be of value to the health of future generations is not lost. International agencies are again providing financial support for a variety of joint studies, some of which are based on studies of tissues from thyroid operations carried out as part of treatment, and not required for the initial diagnosis on which treatment is based. An international coordinated approach to this problem is not in place to help Belarus, the Russian Federation and Ukraine to establish their own comprehensive thyroid tissue and data banks and to ensure that tissue and nucleic acids are used to contribute to the understanding of the consequences of the Chernobyl accident. This project has the support of the Governments of Belarus, the Russian Federation and Ukraine and the National Cancer Institute of the USA, (NCI), the European Commission (EC), the Sasakawa Memorial Health Foundation of Japan (SMHF) and the World Health Organization (WHO) have agreed to cooperate in supporting this project.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with thyroid tumours from the whole of Belarus, and the contaminated oblasts of the Russian Federation and Ukraine who were born after 26th April 1967.
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
Not reported in the source record.
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 2 Jul 2017.
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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.
Louise Brinton, Ph.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 Environment, run by National Cancer Institute (NCI) at 1 site in United States.
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 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 2 Jul 2017. 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 United States. 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.
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 2 Jul 2017.