<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/NCT02229565</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00053535</org_study_id>
    <nct_id>NCT02229565</nct_id>
  </id_info>
  <brief_title>Molecular Mechanisms Underlying Prostate Cancer Disparities</brief_title>
  <acronym>GENCADE</acronym>
  <official_title>Molecular Mechanisms Underlying Prostate Cancer Disparities.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 purpose of this study is to further elucidate the molecular mechanisms underlying&#xD;
      prostate cancer disparities. In previous work the investigators have identified a set of&#xD;
      differentially deregulated genes in African American versus Caucasian American prostate&#xD;
      cancer. Based on these findings, they hypothesize that they will be able to validate these&#xD;
      targets, originally identified in the previous work conducted at The George Washington&#xD;
      University Medical Center, in an independent Duke University Medical Center cohort of&#xD;
      prostate cancer specimens. In addition, the investigators hypothesize that they will be able&#xD;
      to discover novel targets in the Duke University Medical Center cohort of prostate cancer&#xD;
      specimens because of regional differences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individual patient African American and Caucasian American prostate biopsy cores or surgical&#xD;
      specimens will be obtained from the following procedures: transrectal ultrasound biopsy of&#xD;
      the prostate (TRUSBxP), MR fusion biopsy, intra-operatively (IO) at the time of&#xD;
      prostatectomy. Using cellular DNA and RNA, isolated from prostate cancer and patient-matched&#xD;
      normal prostate biopsy cores or surgical specimens, the investigators will perform ancestral&#xD;
      genotyping, exon arrays, targeted RNA sequencing, and epigenetic analyses. As controls, blood&#xD;
      will also be collected. Genomic data from blood and tumor tissue will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">October 14, 2019</completion_date>
  <primary_completion_date type="Actual">October 14, 2019</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>Proportion of high and low expression of identified gene targets in Caucasian and African American specimens</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Total RNA will be interrogated for mRNA expression patterns with the Affymetrix Human Exon 1.0 ST GeneChip. Microarray data will be normalized by quantile normalization with background correction. Targeted RNA sequencing of the previously identified genetic factors specific to African American prostate cancer will confirm altered expression and alternative splicing in these deregulated genes. The Agilent Technologies SureSelect RNA Custom Capture Kit will capture and sequence transcripts. Epigenetic analyses of the genetic factors specific to African American prostate cancer will identify DNA methylation and histone modification patterns in these deregulated genes. The Sequenom EpiTYPER will screen for differential methylation and methylation differences will be quantified using pyrosequencing. Differential histone modification patterns will be explored. Analysis will be performed on 33 prostate cancer biopsy specimens from each of 6 groups stratified by race and Gleason grade.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">226</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Caucasian</arm_group_label>
    <description>Caucasian subjects having a biopsy or prostatectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>African American</arm_group_label>
    <description>African American subjects having a biopsy or prostatectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biopsy or prostatectomy</intervention_name>
    <arm_group_label>African American</arm_group_label>
    <arm_group_label>Caucasian</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes African American and Caucasian American patients&#xD;
        (self-reported) undergoing clinically indicated diagnostic biopsies for a suspected&#xD;
        prostate malignancy or intra-operative biopsies of patients undergoing clinically indicated&#xD;
        prostatectomy for a confirmed prostate cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected malignancy of prostate cancer&#xD;
&#xD;
          -  Self-reported race of African American or Caucasian American&#xD;
&#xD;
          -  Age &gt;/= 18 years&#xD;
&#xD;
          -  Able to read, understand and sign an informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Collected tumor tissue is inadequate for DNA and RNA analysis and/or is not positive&#xD;
             for adenocarcinoma of the prostate.&#xD;
&#xD;
          -  Patients with prior systemic therapy will not be eligible for the study, i.e.&#xD;
             radiation or chemo or immunotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Patierno, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>prostate biopsy</keyword>
  <keyword>prostatectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT02229565
org study id: Pro00053535
nct id: NCT02229565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to further elucidate the molecular mechanisms underlying
      prostate cancer disparities. In previous work the investigators have identified a set of
      differentially deregulated genes in African American versus Caucasian American prostate
      cancer. Based on these findings, they hypothesize that they will be able to validate these
      targets, originally identified in the previous work conducted at The George Washington
      University Medical Center, in an independent Duke University Medical Center cohort of
      prostate cancer specimens. In addition, the investigators hypothesize that they will be able
      to discover novel targets in the Duke University Medical Center cohort of prostate cancer
      specimens because of regional differences.
Individual patient African American and Caucasian American prostate biopsy cores or surgical
      specimens will be obtained from the following procedures: transrectal ultrasound biopsy of
      the prostate (TRUSBxP), MR fusion biopsy, intra-operatively (IO) at the time of
      prostatectomy. Using cellular DNA and RNA, isolated from prostate cancer and patient-matched
      normal prostate biopsy cores or surgical specimens, the investigators will perform ancestral
      genotyping, exon arrays, targeted RNA sequencing, and epigenetic analyses. As controls, blood
      will also be collected. Genomic data from blood and tumor tissue will be compared.
observational model: Cohort
time perspective: Prospective
measure: Proportion of high and low expression of identified gene targets in Caucasian and African American specimens
time frame: up to 2 years
description: Total RNA will be interrogated for mRNA expression patterns with the Affymetrix Human Exon 1.0 ST GeneChip. Microarray data will be normalized by quantile normalization with background correction. Targeted RNA sequencing of the previously identified genetic factors specific to African American prostate cancer will confirm altered expression and alternative splicing in these deregulated genes. The Agilent Technologies SureSelect RNA Custom Capture Kit will capture and sequence transcripts. Epigenetic analyses of the genetic factors specific to African American prostate cancer will identify DNA methylation and histone modification patterns in these deregulated genes. The Sequenom EpiTYPER will screen for differential methylation and methylation differences will be quantified using pyrosequencing. Differential histone modification patterns will be explored. Analysis will be performed on 33 prostate cancer biopsy specimens from each of 6 groups stratified by race and Gleason grade.
arm group label: Caucasian
description: Caucasian subjects having a biopsy or prostatectomy.
arm group label: African American
description: African American subjects having a biopsy or prostatectomy.
intervention type: Device
intervention name: Biopsy or prostatectomy
arm group label: African American
arm group label: Caucasian
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Patierno, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms