<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/NCT02211781</url>
  </required_header>
  <id_info>
    <org_study_id>999914162</org_study_id>
    <secondary_id>14-C-N162</secondary_id>
    <nct_id>NCT02211781</nct_id>
  </id_info>
  <brief_title>Study of Diets and Way of Life of Native Americans and Hispanics in New Mexico During the Time of the Trinity Nuclear Test</brief_title>
  <official_title>A Pilot Study of Dietary and Lifestyle Patterns Among Native Americans and Hispanics/Latinos in New Mexico at the Time of the Trinity Nuclear Test</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;
      - The National Cancer Institute has been studying health risks to people in New Mexico at the&#xD;
      time of the first nuclear bomb test. This was called the Trinity nuclear test. It took place&#xD;
      in 1945. Researchers want to also learn about Native Americans and Hispanics at that time.&#xD;
      They want to learn about their way of life and their diets. This will give a more complete&#xD;
      picture of the health risks to people in New Mexico in 1945.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  To learn about the activities and eating habits of Hispanic and tribal communities&#xD;
           during the 1940s.&#xD;
&#xD;
        -  To see if a group of Hispanic and Native Americans who were living in New Mexico in 1945&#xD;
           can be gathered.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Native American or Hispanic adults who were alive in 1945. They must know firsthand about&#xD;
      the lifestyle and diet in New Mexico at that time.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will have 1 visit. They will be interviewed at a place like a library or&#xD;
           office. They will answer questions about their lifestyle and diet around 1945. This will&#xD;
           take up 60 90 minutes.&#xD;
&#xD;
        -  Participants may agree to have their interviews taped. Their names will not be kept with&#xD;
           their answers from the interviews.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The evaluation of health risks among the public as a consequence of exposure to radioactive&#xD;
      fallout from nuclear testing has been an important area of research for many years by&#xD;
      investigators in the Radiation Epidemiology Branch (REB). As a result of the reputation of&#xD;
      this group in the field of dose and risk assessment related to radioactive fallout, and the&#xD;
      expertise of the National Cancer Institute (NCI) in cancer research, in 2007, U.S. Senator&#xD;
      Jeff Bingaman (D, NM) sent a request to the NCI to evaluate the health risks to New Mexico&#xD;
      residents from the first nuclear bomb test (named Trinity) that was conducted in 1945 in&#xD;
      south-central New Mexico. The NCI responded in early 2008 with a preliminary evaluation of&#xD;
      the radiation doses received by the residents of New Mexico. However, the evaluation made no&#xD;
      special provisions for lifestyles and diets of tribal community members or Hispanics\Latinos&#xD;
      which were a significant part of the population. Little is known about Native American and&#xD;
      Hispanic\Latino lifestyles and diets in the mid-twentieth century, yet such data are&#xD;
      necessary to produce a credible assessment of health risks to the state s population. For&#xD;
      this reason, REB investigators did not publish the initial dose assessment in the&#xD;
      peer-reviewed literature. Additionally, since statewide health records cannot be&#xD;
      reconstructed in a meaningful way to determine excess disease rates, estimation of health&#xD;
      risks in this population can only be projected (i.e., estimated) based on the magnitude and&#xD;
      distribution of radiation doses received and the relationships between radiation dose and&#xD;
      cancer risks observed in other populations. Since the preparation of the 2008 report, the REB&#xD;
      exposure assessment models used to assess doses from radioactive fallout from other nuclear&#xD;
      test sites have been improved and published in the peer-reviewed literature. The required&#xD;
      improvements in the 2008 Trinity assessment that would support publication of the projected&#xD;
      health risks includes sex- and age-dependent diet and lifestyle models for Native Americans&#xD;
      and Hispanics\Latinos in New Mexico in the mid-1940s. We are proposing a pilot study to&#xD;
      collect, via individual interviews, information on lifestyle and diet from up to 9 key&#xD;
      informants of Native Americans and Hispanics\Latinos living in New Mexico who were alive at&#xD;
      the time of the bomb (currently greater than or equal to 69 years old). This data will inform&#xD;
      the design of a larger study, which will collect lifestyle and diet information from a series&#xD;
      of targeted focus groups. The information acquired from these 9 individual interviews will be&#xD;
      used to 1) determine the feasibility of assembling focus groups of members of tribal and&#xD;
      Hispanic\Latino communities in New Mexico who were alive in 1945 at the time of the bomb and&#xD;
      2) provide lifestyle and diet information to be used for refining focus group interviewing&#xD;
      tools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 1, 2014</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diet and Lifestyle</measure>
    <time_frame>September 2014</time_frame>
  </primary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>Lifestyle</condition>
  <condition>Diet</condition>
  <condition>Ionizing Radiation Exposure</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  Data Analysis Only&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>101 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven L Simon</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hellman A, Weislow OS, Twardzik DR, Fowler AK. Type C retrovirus activation and possible functions in the normal and tumor-bearing host. Cancer Res. 1979 Jul;39(7 Pt 2):2902-7.</citation>
    <PMID>221111</PMID>
  </reference>
  <reference>
    <citation>Schwerin M, Schonfeld S, Drozdovitch V, Akimzhanov K, Aldyngurov D, Bouville A, Land C, Luckyanov N, Mabuchi K, Semenova Y, Simon S, Tokaeva A, Zhumadilov Z, Potischman N. The utility of focus group interviews to capture dietary consumption data in the distant past: dairy consumption in Kazakhstan villages 50 years ago. J Dev Orig Health Dis. 2010 Jun;1(3):192-202. doi: 10.1017/S2040174410000243.</citation>
    <PMID>24286002</PMID>
  </reference>
  <verification_date>May 21, 2018</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tribal Communities</keyword>
  <keyword>Radiation</keyword>
  <keyword>Cancer</keyword>
  <!-- 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/NCT02211781
org study id: 999914162
secondary id: 14-C-N162
nct id: NCT02211781
lead sponsor: 
Background:

      - The National Cancer Institute has been studying health risks to people in New Mexico at the
      time of the first nuclear bomb test. This was called the Trinity nuclear test. It took place
      in 1945. Researchers want to also learn about Native Americans and Hispanics at that time.
      They want to learn about their way of life and their diets. This will give a more complete
      picture of the health risks to people in New Mexico in 1945.

      Objectives:

        -  To learn about the activities and eating habits of Hispanic and tribal communities
           during the 1940s.

        -  To see if a group of Hispanic and Native Americans who were living in New Mexico in 1945
           can be gathered.

      Eligibility:

      - Native American or Hispanic adults who were alive in 1945. They must know firsthand about
      the lifestyle and diet in New Mexico at that time.

      Design:

        -  Participants will have 1 visit. They will be interviewed at a place like a library or
           office. They will answer questions about their lifestyle and diet around 1945. This will
           take up 60 90 minutes.

        -  Participants may agree to have their interviews taped. Their names will not be kept with
           their answers from the interviews.
The evaluation of health risks among the public as a consequence of exposure to radioactive
      fallout from nuclear testing has been an important area of research for many years by
      investigators in the Radiation Epidemiology Branch (REB). As a result of the reputation of
      this group in the field of dose and risk assessment related to radioactive fallout, and the
      expertise of the National Cancer Institute (NCI) in cancer research, in 2007, U.S. Senator
      Jeff Bingaman (D, NM) sent a request to the NCI to evaluate the health risks to New Mexico
      residents from the first nuclear bomb test (named Trinity) that was conducted in 1945 in
      south-central New Mexico. The NCI responded in early 2008 with a preliminary evaluation of
      the radiation doses received by the residents of New Mexico. However, the evaluation made no
      special provisions for lifestyles and diets of tribal community members or Hispanics\Latinos
      which were a significant part of the population. Little is known about Native American and
      Hispanic\Latino lifestyles and diets in the mid-twentieth century, yet such data are
      necessary to produce a credible assessment of health risks to the state s population. For
      this reason, REB investigators did not publish the initial dose assessment in the
      peer-reviewed literature. Additionally, since statewide health records cannot be
      reconstructed in a meaningful way to determine excess disease rates, estimation of health
      risks in this population can only be projected (i.e., estimated) based on the magnitude and
      distribution of radiation doses received and the relationships between radiation dose and
      cancer risks observed in other populations. Since the preparation of the 2008 report, the REB
      exposure assessment models used to assess doses from radioactive fallout from other nuclear
      test sites have been improved and published in the peer-reviewed literature. The required
      improvements in the 2008 Trinity assessment that would support publication of the projected
      health risks includes sex- and age-dependent diet and lifestyle models for Native Americans
      and Hispanics\Latinos in New Mexico in the mid-1940s. We are proposing a pilot study to
      collect, via individual interviews, information on lifestyle and diet from up to 9 key
      informants of Native Americans and Hispanics\Latinos living in New Mexico who were alive at
      the time of the bomb (currently greater than or equal to 69 years old). This data will inform
      the design of a larger study, which will collect lifestyle and diet information from a series
      of targeted focus groups. The information acquired from these 9 individual interviews will be
      used to 1) determine the feasibility of assembling focus groups of members of tribal and
      Hispanic\Latino communities in New Mexico who were alive in 1945 at the time of the bomb and
      2) provide lifestyle and diet information to be used for refining focus group interviewing
      tools.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Diet and Lifestyle
time frame: September 2014
criteria: 
gender: All
minimum age: 75 Years
maximum age: 101 Years
healthy volunteers: No
last name: Steven L Simon
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
citation: Hellman A, Weislow OS, Twardzik DR, Fowler AK. Type C retrovirus activation and possible functions in the normal and tumor-bearing host. Cancer Res. 1979 Jul;39(7 Pt 2):2902-7.
PMID: 221111
citation: Schwerin M, Schonfeld S, Drozdovitch V, Akimzhanov K, Aldyngurov D, Bouville A, Land C, Luckyanov N, Mabuchi K, Semenova Y, Simon S, Tokaeva A, Zhumadilov Z, Potischman N. The utility of focus group interviews to capture dietary consumption data in the distant past: dairy consumption in Kazakhstan villages 50 years ago. J Dev Orig Health Dis. 2010 Jun;1(3):192-202. doi: 10.1017/S2040174410000243.
PMID: 24286002
responsible party type: Sponsor