International Cooperation for Post-Cherynobyl NIS Thyroid Tissue and Data Banks

June 30, 2017 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI), 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Louise Brinton, Ph.D., National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 1999

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 16, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 999900024
  • OH00-C-N024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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