<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/NCT03304171</url>
  </required_header>
  <id_info>
    <org_study_id>1998-453</org_study_id>
    <nct_id>NCT03304171</nct_id>
  </id_info>
  <brief_title>Overall Diet Quality and Breast Cancer Risk</brief_title>
  <official_title>Diet Quality Scores and Risk of Incident Breast Cancer in Healthy Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to examine the relationship between indices of overall diet&#xD;
      quality and incident breast cancer risk in a large prospective cohort of women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study examined the role of overall diet quality on the risk of developing invasive&#xD;
      breast cancer among 96,959 women in the California Teachers Study, in which 4,826 women were&#xD;
      diagnosed with breast cancer during follow-up (1995-2011). Participants' dietary habits were&#xD;
      recorded at baseline (1995) using a 103-item Block95 Food Frequency Questionnaire to allow&#xD;
      for the assessment of overall diet quality. Specifically, diet quality was characterized by&#xD;
      the Alternate Mediterranean Diet (aMED), Alternative Healthy Eating Index-2010 (AHEI-2010),&#xD;
      Dietary Approaches to Stop Hypertension (DASH), and Paleolithic Index scores. Associations&#xD;
      between diet quality and the risk of developing breast cancer were examined using&#xD;
      multivariate Cox proportional hazard regression models to provide hazard ratios and&#xD;
      corresponding 95% confidence intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1995</start_date>
  <completion_date type="Actual">December 31, 2011</completion_date>
  <primary_completion_date type="Actual">December 31, 2011</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>Incident Invasive Breast Cancer</measure>
    <time_frame>1995-2011</time_frame>
    <description>All incident cancer cases were identified through linkage with the California Cancer Registry (CCR) records, which is a population-based cancer registry for California residents.</description>
  </primary_outcome>
  <enrollment type="Actual">96959</enrollment>
  <condition>Invasive Breast Cancer</condition>
  <condition>Incident Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Female participants of the California Teachers Study who met the eligibility criteria.&#xD;
&#xD;
        The California Teachers Study is comprised entirely of female participants aged 22-104&#xD;
        years old at enrollment who were current and former public school teachers and&#xD;
        administrators and completed a 16-page mailed questionnaire at study entry in 1995-1996.&#xD;
        Details of the California Teachers Study (CTS) have been described previously (Bernstein L,&#xD;
        et al.; 2002).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with no history of cancer diagnosis prior to baseline.&#xD;
&#xD;
          -  Participants with no history of myocardial infarction prior to baseline.&#xD;
&#xD;
          -  Participants with no history of stroke prior to baseline.&#xD;
&#xD;
          -  Participants with no history of diabetes prior to baseline.&#xD;
&#xD;
          -  Participants who are not missing excessive dietary data.&#xD;
&#xD;
          -  Participants with energy intake values at ≥1% and ≤99% of the population distribution.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <link>
    <url>https://www.calteachersstudy.org/</url>
    <description>California Teacher Study Homepage</description>
  </link>
  <reference>
    <citation>Bernstein L, Allen M, Anton-Culver H, Deapen D, Horn-Ross PL, Peel D, Pinder R, Reynolds P, Sullivan-Halley J, West D, Wright W, Ziogas A, Ross RK. High breast cancer incidence rates among California teachers: results from the California Teachers Study (United States). Cancer Causes Control. 2002 Sep;13(7):625-35. doi: 10.1023/a:1019552126105.</citation>
    <PMID>12296510</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Vikram Haridass</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT03304171
org study id: 1998-453
nct id: NCT03304171
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to examine the relationship between indices of overall diet
      quality and incident breast cancer risk in a large prospective cohort of women.
This study examined the role of overall diet quality on the risk of developing invasive
      breast cancer among 96,959 women in the California Teachers Study, in which 4,826 women were
      diagnosed with breast cancer during follow-up (1995-2011). Participants' dietary habits were
      recorded at baseline (1995) using a 103-item Block95 Food Frequency Questionnaire to allow
      for the assessment of overall diet quality. Specifically, diet quality was characterized by
      the Alternate Mediterranean Diet (aMED), Alternative Healthy Eating Index-2010 (AHEI-2010),
      Dietary Approaches to Stop Hypertension (DASH), and Paleolithic Index scores. Associations
      between diet quality and the risk of developing breast cancer were examined using
      multivariate Cox proportional hazard regression models to provide hazard ratios and
      corresponding 95% confidence intervals.
observational model: Cohort
time perspective: Prospective
measure: Incident Invasive Breast Cancer
time frame: 1995-2011
description: All incident cancer cases were identified through linkage with the California Cancer Registry (CCR) records, which is a population-based cancer registry for California residents.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
url: https://www.calteachersstudy.org/
description: California Teacher Study Homepage
citation: Bernstein L, Allen M, Anton-Culver H, Deapen D, Horn-Ross PL, Peel D, Pinder R, Reynolds P, Sullivan-Halley J, West D, Wright W, Ziogas A, Ross RK. High breast cancer incidence rates among California teachers: results from the California Teachers Study (United States). Cancer Causes Control. 2002 Sep;13(7):625-35. doi: 10.1023/a:1019552126105.
PMID: 12296510
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Vikram Haridass
investigator title: Principal Investigator
mesh term: Breast Neoplasms