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临床试验/NCT02989103
NCT02989103已完成不适用

Hyperthyroid Follow-Up Study

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 35,593 人开始时间: 2016年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35,593
试验地点
1
主要终点
Non-cancer mortality

研究概览

简要总结

Background:

Hyperthyroidism is a common disease. It is very common for women. It is usually treated with Radioiodine (I-131). Some people think that this might cause cancer, even many years later. Past studies of people with hyperthyroidism have not been clear about cancer risks after I-131. Researchers want to look at a group of people with the disease who got I-131 many years ago. They want to look at how their health was months and years later.

Objective:

To learn more about disease risks in relation to radiation from I-131 treatment for hyperthyroidism.

Eligibility:

People who were part of the previous study. These are people who were diagnosed with hyperthyroidism at U.S. and U.K. hospitals from 1946 to 1964. About 95% of the participants have already died.

Design:

Researchers will examine data already collected by the past study. This includes data on participants later cancers and other health outcomes after they had I-131 treatment.

Researchers will compare that data to a National Death Index search.

This was already done for data up through 2003. This study will cover 2004 2014.

Researchers will not be in touch with study participants or their next of kin....

详细描述

Hyperthyroidism (thyrotoxicosis) is a relatively common disease, especially among women, and radioiodine (I-131) administration is the treatment of choice for most adult patients. There is concern about possible carcinogenic effects of I-131 therapy, but previous studies of hyperthyroid patients have not presented clear results regarding cancer risks following I-131 treatment. There also is public concern regarding late health consequences of I-131 exposure as this radioiodine is one of the primary release products from nuclear power generation and a principal component in fallout from nuclear power plant accidents. The Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort, assembled in 1961, comprises 35,000 subjects treated for hyperthyroidism at over 20 medical centers in the US and one in Great Britain between 1946 and 1964. This is among the largest group of hyperthyroid patients that has been followed up for subsequent cancer and other health outcomes. The proposed mortality follow-up study will enable us to assess nearly lifetime risk of cancer and other diseases in this unique cohort. Mortality follow-up data will extend the observation through 2015, adding 15 more years, via linkage with the National Death Index search. Recently estimated I-131 radiation doses to various body organs will allow refined dose response analysis, providing most definitive assessment of the nature and magnitude of the risk of cancer and other disease associated with I-131 exposure as well as end-results of I-131 and other treatment for hyperthyroidism.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Non-cancer mortality

时间窗: 1946 to 2014

Mortality rates due to non-cancer in the cohort population

Cancer mortality rates

时间窗: 1946 to 2014

Mortality rates due to cancer in the cohort population.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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