<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/NCT03289130</url>
  </required_header>
  <id_info>
    <org_study_id>DAMD-11-1-0568</org_study_id>
    <nct_id>NCT03289130</nct_id>
  </id_info>
  <brief_title>Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness</brief_title>
  <acronym>PCaP</acronym>
  <official_title>The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Carolina</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>
      The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of&#xD;
      over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in&#xD;
      prostate cancer aggressiveness and survival through a comprehensive evaluation of social,&#xD;
      individual, and tumor level influences on prostate cancer aggressiveness. Project 3&#xD;
      specifically aims to examine nutritional modulation of prostate cancer aggressiveness using&#xD;
      dietary assessment and biomarker-based data on dietary factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 2,258 (1,130 African Americans and 1128 European Americans) men newly diagnosed&#xD;
      with prostate cancer in North Carolina and Louisiana were enrolled into the study between&#xD;
      2004 and 2009. Participants signed informed consent and were interviewed by a trained nurse&#xD;
      who collected information on demographics, occupation, family history, health status, health&#xD;
      care, prostate cancer diagnosis and screening history, medication use, anthropometrics,&#xD;
      lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. Research&#xD;
      subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a&#xD;
      modified version of the National Cancer Institute Diet History Questionnaire. Vitamin and&#xD;
      supplement use in the year prior to prostate cancer diagnosis was assessed via a validated&#xD;
      questionnaire, and current use was assessed by bottle label inventory. Blood, urine, and&#xD;
      adipose tissue samples were collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2004</start_date>
  <completion_date type="Actual">August 2009</completion_date>
  <primary_completion_date type="Actual">August 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>High aggressive prostate cancer</measure>
    <time_frame>Baseline (cross-sectional study)</time_frame>
    <description>Gleason score&gt;=8, or PSA&gt;20ng/ml, or Gleason score&gt;7 and clinical stage T3-T4</description>
  </primary_outcome>
  <enrollment type="Actual">2258</enrollment>
  <condition>Prostatic Neoplasm</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, serum, urine, adipose tissue, DNA extracted from whole blood, frozen tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Residents of North Carolina and Louisiana with a first diagnosis of prostate cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first diagnosis of histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  40-79 years old at diagnosis,&#xD;
&#xD;
          -  can complete the study interview in English,&#xD;
&#xD;
          -  do not live in an institution (nursing home),&#xD;
&#xD;
          -  are not cognitively impaired or in a severely debilitated physical state,&#xD;
&#xD;
          -  are not under the influence of alcohol, severely medicated, or apparently psychotic at&#xD;
             the time of the interview.&#xD;
&#xD;
          -  must self-identify as at least part African American/Black or Caucasian&#xD;
             American/White/European American.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only males were enrolled (prostate cancer only occurs in males).</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Susan E Steck</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Carolina</affiliation>
  </overall_official>
  <reference>
    <citation>Schroeder JC, Bensen JT, Su LJ, Mishel M, Ivanova A, Smith GJ, Godley PA, Fontham ET, Mohler JL. The North Carolina-Louisiana Prostate Cancer Project (PCaP): methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. Prostate. 2006 Aug 1;66(11):1162-76. doi: 10.1002/pros.20449.</citation>
    <PMID>16676364</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Carolina</investigator_affiliation>
    <investigator_full_name>Susan Steck</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data may be requested from PCaP through a centralized data request process.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data are currently available indefinitely.</ipd_time_frame>
    <ipd_url>https://pcap.bioinf.unc.edu/</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://pcap.bioinf.unc.edu/</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03289130
org study id: DAMD-11-1-0568
nct id: NCT03289130
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of
      over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in
      prostate cancer aggressiveness and survival through a comprehensive evaluation of social,
      individual, and tumor level influences on prostate cancer aggressiveness. Project 3
      specifically aims to examine nutritional modulation of prostate cancer aggressiveness using
      dietary assessment and biomarker-based data on dietary factors.
A total of 2,258 (1,130 African Americans and 1128 European Americans) men newly diagnosed
      with prostate cancer in North Carolina and Louisiana were enrolled into the study between
      2004 and 2009. Participants signed informed consent and were interviewed by a trained nurse
      who collected information on demographics, occupation, family history, health status, health
      care, prostate cancer diagnosis and screening history, medication use, anthropometrics,
      lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. Research
      subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a
      modified version of the National Cancer Institute Diet History Questionnaire. Vitamin and
      supplement use in the year prior to prostate cancer diagnosis was assessed via a validated
      questionnaire, and current use was assessed by bottle label inventory. Blood, urine, and
      adipose tissue samples were collected.
observational model: Case-Only
time perspective: Cross-Sectional
measure: High aggressive prostate cancer
time frame: Baseline (cross-sectional study)
description: Gleason score>=8, or PSA>20ng/ml, or Gleason score>7 and clinical stage T3-T4
Plasma, serum, urine, adipose tissue, DNA extracted from whole blood, frozen tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Only males were enrolled (prostate cancer only occurs in males).
minimum age: 40 Years
maximum age: 79 Years
last name: Susan E Steck
role: Principal Investigator
affiliation: University of South Carolina
citation: Schroeder JC, Bensen JT, Su LJ, Mishel M, Ivanova A, Smith GJ, Godley PA, Fontham ET, Mohler JL. The North Carolina-Louisiana Prostate Cancer Project (PCaP): methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. Prostate. 2006 Aug 1;66(11):1162-76. doi: 10.1002/pros.20449.
PMID: 16676364
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Susan Steck
investigator title: Associate Professor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: Deidentified data may be requested from PCaP through a centralized data request process.
ipd info type: Study Protocol
ipd time frame: Data are currently available indefinitely.
ipd url: https://pcap.bioinf.unc.edu/
study doc: 