All-Cause MortalityNCT02989103
Hyperthyroid Follow-Up Study
An observational study of All-Cause Mortality and Circulatory and Other Disease Mortality, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- All-Cause Mortality, Circulatory and Other Disease Mortality, Thyroid and Other Cancer Mortality
- How many people
- 35,593 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2016to 28 Oct 2020
- 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 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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%).
Who may be able to join
- Individuals treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.
Who cannot join
- Any individual that was NOT treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.
Trial locations and contacts
1 site in 1 country.
United States1 site
Social and Scientific Systems, Inc.
Durham, North Carolina, 27703
About this 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.
Read more
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....
Read the detailed description
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.
- Conditions
- All-Cause Mortality, Circulatory and Other Disease Mortality, Thyroid and Other Cancer Mortality
- Keywords
- Hyperthyroidism, Radiation, Mortality
- Medical subject headings
- Thyroid Diseases, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthyroidism Follow-up Cohort Study | Hyperthyroid patients enrolled and treated between 1946 and 1964 in 25 U.S. and 1 UK site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer mortality rates
Mortality rates due to cancer in the cohort population.
Measured: 1946 to 2014
Non-cancer mortality
Mortality rates due to non-cancer in the cohort population
Measured: 1946 to 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start6 Dec 2016
- Primary completion1 Sep 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for All-Cause MortalityStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35,593 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Cari M Kitahara, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989103
- Sponsor's protocol ID
- 999917021
- Other IDs
- 17-C-N021
- Status last verified
- Oct 2020
- First submitted
- 6 Dec 2016
- Last updated
- 29 Oct 2020
- Results posted
- No
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.
PubMed 31260066Dobyns 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.
PubMed 4134013Ron 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.
PubMed 9686552
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperthyroid Follow-Up Study
- ClinicalTrials.gov ID
- NCT02989103
- Acronym / sponsor ID
- 999917021
- Conditions
- All-Cause Mortality, Circulatory and Other Disease Mortality, Thyroid and Other Cancer Mortality
- Keywords
- Hyperthyroidism, Radiation, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,593 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 12 Dec 2016 (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.
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....
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthyroidism Follow-up Cohort Study | – | –Hyperthyroid patients enrolled and treated between 1946 and 1964 in 25 U.S. and 1 UK site |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%).
Key inclusion criteria (1 listed)
- Individuals treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.
Key exclusion criteria (1 listed)
- Any individual that was NOT treated for hyperthyroidism registered within the Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.
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
Cancer mortality rates
Time frame: 1946 to 2014
Mortality rates due to cancer in the cohort population.
Non-cancer mortality
Time frame: 1946 to 2014
Mortality rates due to non-cancer in the cohort population
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 29 Oct 2020.
- Background: PubMed 31260066Kitahara 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.
- Background: PubMed 4134013Dobyns 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.
- Background: PubMed 9686552Ron 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.
Related trials for All-Cause Mortality
Not yet recruitingObservational study
Stress Hyperglycemia Ratio and Glucose Variability in Critically Ill Patients
Critical Illness, Hyperglycemia
Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
Active, not recruitingPhase 3
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
Kidney Disease, Chronic, Renal Transplant Failure
Not yet recruitingObservational study
Evaluation of Three Trauma Mortality Scores in Adults Admitted to Intensive Care in Tunisia
Wounds and Injuries, Mortality
Not yet recruiting
A Cluster-Randomized Controlled Trial
Hypertension, Stroke
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.
Cari M Kitahara 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 All-Cause Mortality and Circulatory and Other Disease Mortality, 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 1 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 29 Oct 2020. 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.
What does the primary outcome measure?
Cancer mortality rates (time frame: 1946 to 2014). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989103, which also lists 3 linked publications.
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 29 Oct 2020.