<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/NCT01664169</url>
  </required_header>
  <id_info>
    <org_study_id>A151201</org_study_id>
    <secondary_id>CDR0000738204</secondary_id>
    <secondary_id>NCI-2012-01994</secondary_id>
    <nct_id>NCT01664169</nct_id>
  </id_info>
  <brief_title>Biomarkers in Plasma Specimens From Patients Treated on Study CALGB-80303</brief_title>
  <official_title>Validation of Circulating Biomarkers Using the Immunological Multiparameter Chip Technology (IMPACT) on Plasma Specimens Collected on CALGB 80303</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance for Clinical Trials in Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance for Clinical Trials in Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may&#xD;
      help doctors identify and learn more about biomarkers related to cancer.&#xD;
&#xD;
      PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic&#xD;
      cancer treated on study CALGB-80303.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
        -  To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for&#xD;
           overall survival (OS) in study BO17706 can be replicated in study CALGB-80303 using the&#xD;
           same Immunological Multiparameter Chip Technology (IMPACT) assay.&#xD;
&#xD;
        -  To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for&#xD;
           progression-free survival (PFS), and other circulating biomarkers in study BO17706, can&#xD;
           be replicated in study CALGB-80303 using the same IMPACT assay.&#xD;
&#xD;
        -  To explore the relationship between efficacy and other biomarkers measured in the plasma&#xD;
           samples.&#xD;
&#xD;
      OUTLINE: The samples required for this study are stored in the CALGB Pathology Coordinating&#xD;
      Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No&#xD;
      additional samples are required from patients.&#xD;
&#xD;
      The following markers are analyzed in EDTA plasma samples using the Immunological&#xD;
      MultiParameter Chip Technology (IMPACT) a Roche proprietary multiplex enzyme-linked&#xD;
      immunosorbent assay (ELISA) platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3,&#xD;
      IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Overall survival</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and percentage of responder</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">307</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Single group</arm_group_label>
    <description>The samples required for this study are stored in the CALGB Pathology Coordinating Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No additional samples are required from patients.&#xD;
The following markers are analyzed in EDTA plasma samples using the IMPACT a Roche proprietary multiplex ELISA platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <arm_group_label>Single group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The following markers are analyzed in EDTA plasma samples using the IMPACT a Roche&#xD;
      proprietary multiplex ELISA platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3,&#xD;
      IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with pancreatic cancer and previously enrolled on CALGB-80303.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients must have been registered to CALGB-80303&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas&#xD;
&#xD;
          -  Locally advanced or metastatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herbert Pang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CALGB Statistical Office at Duke University Medical Center</affiliation>
  </overall_official>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adenocarcinoma of the pancreas</keyword>
  <keyword>recurrent pancreatic cancer</keyword>
  <keyword>stage III pancreatic cancer</keyword>
  <keyword>stage IV pancreatic cancer</keyword>
  <keyword>stage IIB pancreatic cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic 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/NCT01664169
org study id: A151201
secondary id: CDR0000738204
secondary id: NCI-2012-01994
nct id: NCT01664169
lead sponsor: 
collaborator: 
has dmc: No
RATIONALE: Studying plasma samples from patients with pancreatic cancer in the laboratory may
      help doctors identify and learn more about biomarkers related to cancer.

      PURPOSE: This research trial studies biomarkers in samples from patients with pancreatic
      cancer treated on study CALGB-80303.
OBJECTIVES:

        -  To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for
           overall survival (OS) in study BO17706 can be replicated in study CALGB-80303 using the
           same Immunological Multiparameter Chip Technology (IMPACT) assay.

        -  To determine whether the observed predictive value of plasma VEGF-A and VEGF-R2 for
           progression-free survival (PFS), and other circulating biomarkers in study BO17706, can
           be replicated in study CALGB-80303 using the same IMPACT assay.

        -  To explore the relationship between efficacy and other biomarkers measured in the plasma
           samples.

      OUTLINE: The samples required for this study are stored in the CALGB Pathology Coordinating
      Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No
      additional samples are required from patients.

      The following markers are analyzed in EDTA plasma samples using the Immunological
      MultiParameter Chip Technology (IMPACT) a Roche proprietary multiplex enzyme-linked
      immunosorbent assay (ELISA) platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3,
      IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival
time frame: 1 month
measure: Progression free survival
time frame: 1 month
measure: Number and percentage of responder
time frame: 1 month
arm group label: Single group
description: The samples required for this study are stored in the CALGB Pathology Coordinating Office at The Ohio State University from patients enrolled on protocol CALGB-80303. No additional samples are required from patients.
The following markers are analyzed in EDTA plasma samples using the IMPACT a Roche proprietary multiplex ELISA platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3, IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.
intervention type: Other
intervention name: laboratory biomarker analysis
arm group label: Single group
The following markers are analyzed in EDTA plasma samples using the IMPACT a Roche
      proprietary multiplex ELISA platform: VEGF-A, VEGF-C, VEGF-R1, VEGF-R2, E-selectin, VEGF-R3,
      IL-8, bFGF, PDGF-C, ICAM-1, and PlGF.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Herbert Pang, PhD
role: Principal Investigator
affiliation: CALGB Statistical Office at Duke University Medical Center
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms