- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02989103
Hyperthyroid Follow-Up Study
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....
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27703
- Social and Scientific Systems, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION:
Individuals treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.
EXCLUSION:
Any individual that was NOT treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hyperthyroidism Follow-up Cohort Study
Hyperthyroid patients enrolled and treated between 1946 and 1964 in 25 U.S. and 1 UK site
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer mortality rates
Time Frame: 1946 to 2014
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Mortality rates due to cancer in the cohort population.
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1946 to 2014
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Non-cancer mortality
Time Frame: 1946 to 2014
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Mortality rates due to non-cancer in the cohort population
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1946 to 2014
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kitahara CM, Berrington de Gonzalez A, Bouville A, Brill AB, Doody MM, Melo DR, Simon SL, Sosa JA, Tulchinsky M, Villoing D, Preston DL. Association of Radioactive Iodine Treatment With Cancer Mortality in Patients With Hyperthyroidism. JAMA Intern Med. 2019 Aug 1;179(8):1034-1042. doi: 10.1001/jamainternmed.2019.0981. Erratum In: JAMA Intern Med. 2019 Aug 1;179(8):1152.
- Dobyns BM, Sheline GE, Workman JB, Tompkins EA, McConahey WM, Becker DV. Malignant and benign neoplasms of the thyroid in patients treated for hyperthyroidism: a report of the cooperative thyrotoxicosis therapy follow-up study. J Clin Endocrinol Metab. 1974 Jun;38(6):976-98. doi: 10.1210/jcem-38-6-976. No abstract available.
- Ron E, Doody MM, Becker DV, Brill AB, Curtis RE, Goldman MB, Harris BS 3rd, Hoffman DA, McConahey WM, Maxon HR, Preston-Martin S, Warshauer ME, Wong FL, Boice JD Jr. Cancer mortality following treatment for adult hyperthyroidism. Cooperative Thyrotoxicosis Therapy Follow-up Study Group. JAMA. 1998 Jul 22-29;280(4):347-55. doi: 10.1001/jama.280.4.347.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999917021
- 17-C-N021
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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