<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/NCT03282812</url>
  </required_header>
  <id_info>
    <org_study_id>CPSII_BRCA_NCC</org_study_id>
    <nct_id>NCT03282812</nct_id>
  </id_info>
  <brief_title>Metabolomics and Breast Cancer Risk in a Nested Case-control Study of the Cancer Prevention Study-II Nutrition Cohort</brief_title>
  <official_title>Cancer Prevention Study-II Nutrition Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American Cancer Society, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate diet, lifestyles, serum metabolomics in relation to breast&#xD;
      cancer risk in a nested case-control study including 1,547 postmenopausal women from the&#xD;
      Cancer Prevention Study II (CPS-II) Nutrition Cohort. The CPS-II Nutrition Cohort is a&#xD;
      prospective cohort study of cancer incidence and mortality among 184,185 men and women,&#xD;
      established by the American Cancer Society in 1992. Participants completed a&#xD;
      self-administered baseline questionnaire in 1992/1993 including demographic, medical, and&#xD;
      lifestyle information. Follow-up questionnaires were sent to living participants in 1997 and&#xD;
      every other year to update exposure information and ascertain newly diagnosed cancers. From&#xD;
      June 1998 through May 2001, blood specimens were collected from 21,963 women. All&#xD;
      participants completed a short questionnaire and provided informed consent at the time of&#xD;
      blood draw. Non-fasting whole blood collected from each participant was shipped chilled&#xD;
      overnight to a central repository, processed, and frozen in liquid nitrogen at approximately&#xD;
      -130 °C for long-term storage.&#xD;
&#xD;
      Of the 21,963 women who provided a blood sample, investigators identified 782 postmenopausal&#xD;
      women diagnosed with invasive breast cancer between blood draw date and June 2011 who had not&#xD;
      been diagnosed with cancer (other than nonmelanoma skin cancer) before blood draw or prior to&#xD;
      their breast cancer diagnosis. Controls were 1:1 matched to cases on date of birth, date of&#xD;
      blood draw, and race and were cancer free at the date of case diagnosis. Seventeen women who&#xD;
      were selected as controls were later diagnosed with breast cancer, at which time they became&#xD;
      a case. A total of 1,547 postmenopausal women were included in the breast cancer nested&#xD;
      case-control study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1998</start_date>
  <completion_date type="Actual">May 2001</completion_date>
  <primary_completion_date type="Actual">May 2001</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incident invasive breast cancer</measure>
    <time_frame>Blood draw through June 30, 2011</time_frame>
    <description>Identified through medical record or linkage with state cancer registry</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1547</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>cases</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
  </arm_group>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  blood sample&#xD;
&#xD;
          -  cancer free at blood draw&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unverified breast cancer&#xD;
&#xD;
          -  non-invasive breast cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <reference>
    <citation>Calle EE, Rodriguez C, Jacobs EJ, Almon ML, Chao A, McCullough ML, Feigelson HS, Thun MJ. The American Cancer Society Cancer Prevention Study II Nutrition Cohort: rationale, study design, and baseline characteristics. Cancer. 2002 May 1;94(9):2490-501. doi: 10.1002/cncr.101970.</citation>
    <PMID>12015775</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03282812
org study id: CPSII_BRCA_NCC
nct id: NCT03282812
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate diet, lifestyles, serum metabolomics in relation to breast
      cancer risk in a nested case-control study including 1,547 postmenopausal women from the
      Cancer Prevention Study II (CPS-II) Nutrition Cohort. The CPS-II Nutrition Cohort is a
      prospective cohort study of cancer incidence and mortality among 184,185 men and women,
      established by the American Cancer Society in 1992. Participants completed a
      self-administered baseline questionnaire in 1992/1993 including demographic, medical, and
      lifestyle information. Follow-up questionnaires were sent to living participants in 1997 and
      every other year to update exposure information and ascertain newly diagnosed cancers. From
      June 1998 through May 2001, blood specimens were collected from 21,963 women. All
      participants completed a short questionnaire and provided informed consent at the time of
      blood draw. Non-fasting whole blood collected from each participant was shipped chilled
      overnight to a central repository, processed, and frozen in liquid nitrogen at approximately
      -130 °C for long-term storage.

      Of the 21,963 women who provided a blood sample, investigators identified 782 postmenopausal
      women diagnosed with invasive breast cancer between blood draw date and June 2011 who had not
      been diagnosed with cancer (other than nonmelanoma skin cancer) before blood draw or prior to
      their breast cancer diagnosis. Controls were 1:1 matched to cases on date of birth, date of
      blood draw, and race and were cancer free at the date of case diagnosis. Seventeen women who
      were selected as controls were later diagnosed with breast cancer, at which time they became
      a case. A total of 1,547 postmenopausal women were included in the breast cancer nested
      case-control study.
observational model: Case-Control
time perspective: Prospective
measure: Incident invasive breast cancer
time frame: Blood draw through June 30, 2011
description: Identified through medical record or linkage with state cancer registry
arm group label: cases
arm group label: controls
criteria: 
gender: Female
gender based: Yes
minimum age: 50 Years
maximum age: N/A
citation: Calle EE, Rodriguez C, Jacobs EJ, Almon ML, Chao A, McCullough ML, Feigelson HS, Thun MJ. The American Cancer Society Cancer Prevention Study II Nutrition Cohort: rationale, study design, and baseline characteristics. Cancer. 2002 May 1;94(9):2490-501. doi: 10.1002/cncr.101970.
PMID: 12015775
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided