NCT02989103

Brief Summary

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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,593

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2020

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

3.7 years

First QC Date

December 6, 2016

Last Update Submit

October 28, 2020

Conditions

All-Cause MortalityCirculatory and Other Disease MortalityThyroid and Other Cancer Mortality

Keywords

HyperthyroidismRadiationMortality

Outcome Measures

Primary Outcomes (2)

  • Cancer mortality rates

    Mortality rates due to cancer in the cohort population.

    1946 to 2014

  • Non-cancer mortality

    Mortality rates due to non-cancer in the cohort population

    1946 to 2014

Study Arms (1)

Hyperthyroidism Follow-up Cohort Study

Hyperthyroid patients enrolled and treated between 1946 and 1964 in 25 U.S. and 1 UK site

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The cohort includes all hypothyroid patients treated with I-131, thyroid surgery, anti-thyroid drugs, or any combinations of these treatments between 1946 and 1964 at 25 U.S. and 1 UK institution. The cohort is largely female (79%), with a mean age at study entry (in 1961) of 46 years old. Hyperthyroidism patients in the cohort are classified as those with Graves disease (91%), toxic nodular goiter (8%), and unknown (1%).

You may qualify if:

  • Individuals treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.

You may not qualify if:

  • Any individual that was NOT treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social and Scientific Systems, Inc.

Durham, North Carolina, 27703, United States

Location

Related Publications (3)

  • 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.

    PMID: 31260066BACKGROUND

  • 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.

    PMID: 4134013BACKGROUND

  • 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.

    PMID: 9686552BACKGROUND

MeSH Terms

Conditions

Thyroid DiseasesHyperthyroidism

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Cari M Kitahara

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 12, 2016

Study Start

December 6, 2016

Primary Completion

September 1, 2020

Study Completion

October 28, 2020

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

US(1)