<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/NCT01672905</url>
  </required_header>
  <id_info>
    <org_study_id>CDR0000738979</org_study_id>
    <secondary_id>ECOG-E9802T1</secondary_id>
    <nct_id>NCT01672905</nct_id>
  </id_info>
  <brief_title>PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802</brief_title>
  <official_title>Evaluation of PSA Antibody on E9802: Confirmation and Concordance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Cooperative Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Cooperative Oncology Group</source>
  <brief_summary>
    <textblock>
      RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the&#xD;
      laboratory may help doctors identify and learn more about biomarkers related to cancer.&#xD;
&#xD;
      PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in&#xD;
      samples from patients treated for prostate cancer on trial ECOG-E9802.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
      Primary&#xD;
&#xD;
        -  To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among&#xD;
           patients treated on ECOG-E9802.&#xD;
&#xD;
      Secondary&#xD;
&#xD;
        -  To characterize the concordance of PSA antibody assessment between the ECOG Immunology&#xD;
           Laboratory and the NCI Immunology Laboratory.&#xD;
&#xD;
      OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time&#xD;
      (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI&#xD;
      Immunology Laboratory. Results are compared between the laboratories.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2012</start_date>
  <completion_date type="Actual">January 7, 2013</completion_date>
  <primary_completion_date type="Actual">January 7, 2013</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Samples from patients who participated in E9802 and provided samples for research&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        DISEASE CHARACTERISTICS: Samples collected on ECOG-E9802 (A Phase II Study of PROSTVAC-V&#xD;
        (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox/TRICOM with GM-CSF in Patients with PSA&#xD;
        Progression after Local Therapy for Prostate Cancer)&#xD;
&#xD;
        PATIENT CHARACTERISTICS:&#xD;
&#xD;
          -  Not specified&#xD;
&#xD;
        PRIOR CONCURRENT THERAPY:&#xD;
&#xD;
          -  Not specified&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert S. DiPaola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
  </overall_official>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>May 16, 2017</last_update_submitted>
  <last_update_submitted_qc>May 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>recurrent prostate cancer</keyword>
  <keyword>stage I prostate cancer</keyword>
  <keyword>stage IIA prostate cancer</keyword>
  <keyword>stage IIB prostate cancer</keyword>
  <keyword>stage III prostate cancer</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/NCT01672905
org study id: CDR0000738979
secondary id: ECOG-E9802T1
nct id: NCT01672905
lead sponsor: 
collaborator: 
RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the
      laboratory may help doctors identify and learn more about biomarkers related to cancer.

      PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in
      samples from patients treated for prostate cancer on trial ECOG-E9802.
OBJECTIVES:

      Primary

        -  To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among
           patients treated on ECOG-E9802.

      Secondary

        -  To characterize the concordance of PSA antibody assessment between the ECOG Immunology
           Laboratory and the NCI Immunology Laboratory.

      OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time
      (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI
      Immunology Laboratory. Results are compared between the laboratories.
observational model: Cohort
time perspective: Retrospective
measure: PSA antibody levels are compared between baseline and follow-up at 12 weeks, as well as 24 weeks, using Wilcoxon signed-rank test
time frame: 12 weeks
measure: Concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory; concordance correlation coefficient will be computed
time frame: 12 Weeks
intervention type: Other
intervention name: laboratory biomarker analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Robert S. DiPaola, MD
role: Principal Investigator
affiliation: Rutgers Cancer Institute of New Jersey
responsible party type: Sponsor
mesh term: Prostatic Neoplasms