<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989103</url>
  </required_header>
  <id_info>
    <org_study_id>999917021</org_study_id>
    <secondary_id>17-C-N021</secondary_id>
    <nct_id>NCT02989103</nct_id>
  </id_info>
  <brief_title>Hyperthyroid Follow-Up Study</brief_title>
  <official_title>Hyperthyroid Follow-Up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Hyperthyroidism is a common disease. It is very common for women. It is usually treated with&#xD;
      Radioiodine (I-131). Some people think that this might cause cancer, even many years later.&#xD;
      Past studies of people with hyperthyroidism have not been clear about cancer risks after&#xD;
      I-131. Researchers want to look at a group of people with the disease who got I-131 many&#xD;
      years ago. They want to look at how their health was months and years later.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To learn more about disease risks in relation to radiation from I-131 treatment for&#xD;
      hyperthyroidism.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People who were part of the previous study. These are people who were diagnosed with&#xD;
      hyperthyroidism at U.S. and U.K. hospitals from 1946 to 1964. About 95% of the participants&#xD;
      have already died.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Researchers will examine data already collected by the past study. This includes data on&#xD;
      participants later cancers and other health outcomes after they had I-131 treatment.&#xD;
&#xD;
      Researchers will compare that data to a National Death Index search.&#xD;
&#xD;
      This was already done for data up through 2003. This study will cover 2004 2014.&#xD;
&#xD;
      Researchers will not be in touch with study participants or their next of kin....&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperthyroidism (thyrotoxicosis) is a relatively common disease, especially among women, and&#xD;
      radioiodine (I-131) administration is the treatment of choice for most adult patients. There&#xD;
      is concern about possible carcinogenic effects of I-131 therapy, but previous studies of&#xD;
      hyperthyroid patients have not presented clear results regarding cancer risks following I-131&#xD;
      treatment. There also is public concern regarding late health consequences of I-131 exposure&#xD;
      as this radioiodine is one of the primary release products from nuclear power generation and&#xD;
      a principal component in fallout from nuclear power plant accidents. The Thyrotoxicosis&#xD;
      Therapy Follow-up Study (TTFUS) cohort, assembled in 1961, comprises 35,000 subjects treated&#xD;
      for hyperthyroidism at over 20 medical centers in the US and one in Great Britain between&#xD;
      1946 and 1964. This is among the largest group of hyperthyroid patients that has been&#xD;
      followed up for subsequent cancer and other health outcomes. The proposed mortality follow-up&#xD;
      study will enable us to assess nearly lifetime risk of cancer and other diseases in this&#xD;
      unique cohort. Mortality follow-up data will extend the observation through 2015, adding 15&#xD;
      more years, via linkage with the National Death Index search. Recently estimated I-131&#xD;
      radiation doses to various body organs will allow refined dose response analysis, providing&#xD;
      most definitive assessment of the nature and magnitude of the risk of cancer and other&#xD;
      disease associated with I-131 exposure as well as end-results of I-131 and other treatment&#xD;
      for hyperthyroidism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">October 28, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cancer mortality rates</measure>
    <time_frame>1946 to 2014</time_frame>
    <description>Mortality rates due to cancer in the cohort population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-cancer mortality</measure>
    <time_frame>1946 to 2014</time_frame>
    <description>Mortality rates due to non-cancer in the cohort population</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35593</enrollment>
  <condition>All-Cause Mortality</condition>
  <condition>Circulatory and Other Disease Mortality</condition>
  <condition>Thyroid and Other Cancer Mortality</condition>
  <arm_group>
    <arm_group_label>Hyperthyroidism Follow-up Cohort Study</arm_group_label>
    <description>Hyperthyroid patients enrolled and treated between 1946 and 1964 in 25 U.S. and 1 UK site</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The cohort includes all hypothyroid patients treated with I-131, thyroid surgery,&#xD;
        anti-thyroid drugs, or any combinations of these treatments between 1946 and 1964 at 25&#xD;
        U.S. and 1 UK institution. The cohort is largely female (79%), with a mean age at study&#xD;
        entry (in 1961) of 46 years old. Hyperthyroidism patients in the cohort are classified as&#xD;
        those with Graves disease (91%), toxic nodular goiter (8%), and unknown (1%).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION:&#xD;
&#xD;
        Individuals treated for hyperthyroidism registered within the Thyrotoxicosis Therapy&#xD;
        Follow-up Study (TTFUS) cohort that was assembled in 1961.&#xD;
&#xD;
        EXCLUSION:&#xD;
&#xD;
        Any individual that was NOT treated for hyperthyroidism registered within the&#xD;
        Thyrotoxicosis Therapy Follow-up Study (TTFUS) cohort that was assembled in 1961.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cari M Kitahara</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Social and Scientific Systems, Inc.</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>31260066</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>4134013</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9686552</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperthyroidism</keyword>
  <keyword>Radiation</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperthyroidism</mesh_term>
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989103
org study id: 999917021
secondary id: 17-C-N021
nct id: NCT02989103
lead sponsor: 
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....
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.
observational model: Cohort
time perspective: Prospective
measure: Cancer mortality rates
time frame: 1946 to 2014
description: Mortality rates due to cancer in the cohort population.
measure: Non-cancer mortality
time frame: 1946 to 2014
description: Mortality rates due to non-cancer in the cohort population
arm group label: Hyperthyroidism Follow-up Cohort Study
description: Hyperthyroid patients enrolled and treated between 1946 and 1964 in 25 U.S. and 1 UK site
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 105 Years
healthy volunteers: No
last name: Cari M Kitahara
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
citation: 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.
PMID: 31260066
citation: 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: 4134013
citation: 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: 9686552
responsible party type: Sponsor
mesh term: Hyperthyroidism
mesh term: Disease