<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/NCT01666184</url>
  </required_header>
  <id_info>
    <org_study_id>T3212</org_study_id>
    <nct_id>NCT01666184</nct_id>
  </id_info>
  <brief_title>Biomarkers Study in Pancreatic Cancer</brief_title>
  <official_title>Biomarkers Study in Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Health Research Institutes, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mackay Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaohsiung Veterans General Hospital.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaohsiung Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Health Research Institutes, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Design:&#xD;
&#xD;
      Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for&#xD;
      pancreatic cancer; (3) willing to sign informed consent.&#xD;
&#xD;
      The pancreatic tumor, tissue specimen and blood sample before or after treatment will be&#xD;
      collected from department of pathology, surgery or diagnostic medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since&#xD;
      the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a&#xD;
      year. The patient enrollment will be completed in 4 years. Clinical follow-up will be&#xD;
      completed in another one year. Data analysis and correlation study may be finished in the end&#xD;
      of 5th year of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Biomarkers Study in Pancreatic Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The specimen and clinical information will be collected and delivered to the laboratory of&#xD;
      Dr. Hui-Ju Ch'ang over NICR, NHRI, Tainan .&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We expect to collect tissue samples from 270 pancreatic cancer patients of resectable&#xD;
        pancreatic cancer. Since the enrollment criteria are not limited to new patients, we expect&#xD;
        to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical&#xD;
        follow-up will be completed in another one year. Data analysis and correlation study may be&#xD;
        finished in the end of 5th year of this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients enrolled to TCOG 3207 study: A Randomized Phase III Study of Adjuvant&#xD;
             Gemcitabine versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer&#xD;
             Underwent Curative Intent (R0 / R1) Resection.&#xD;
&#xD;
          2. Patients who were not eligible for TCOG 3207 study but received surgery or biopsy for&#xD;
             pancreatic cancer.&#xD;
&#xD;
          3. Patients have to sign informed consent for tissue specimen collection, according to&#xD;
             the regulation of DOH.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Ming Shyr, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Veterans General Hospital, Taiwan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tsann-Long Hwang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ruey-Kuen Hsieh, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mackay Memorial Hospital Taipei, Taiwan</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biomarkers study</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/NCT01666184
org study id: T3212
nct id: NCT01666184
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Study Design:

      Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for
      pancreatic cancer; (3) willing to sign informed consent.

      The pancreatic tumor, tissue specimen and blood sample before or after treatment will be
      collected from department of pathology, surgery or diagnostic medicine.
We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since
      the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a
      year. The patient enrollment will be completed in 4 years. Clinical follow-up will be
      completed in another one year. Data analysis and correlation study may be finished in the end
      of 5th year of this study.
observational model: Case-Only
time perspective: Prospective
The specimen and clinical information will be collected and delivered to the laboratory of
      Dr. Hui-Ju Ch'ang over NICR, NHRI, Tainan .
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yi-Ming Shyr, M.D.
role: Principal Investigator
affiliation: Taipei Veterans General Hospital, Taiwan
last name: Tsann-Long Hwang, M.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Ruey-Kuen Hsieh, M.D.
role: Principal Investigator
affiliation: Mackay Memorial Hospital Taipei, Taiwan
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms