<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/NCT01680575</url>
  </required_header>
  <id_info>
    <org_study_id>NEPACA-OVCA</org_study_id>
    <nct_id>NCT01680575</nct_id>
  </id_info>
  <brief_title>Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer</brief_title>
  <official_title>Development of a Risk Model Predicting Chemotherapy-induced Grade 3-4 Neutropenia by Paclitaxel/Carboplatin in Epithelial Ovarian Cancer: Prospective Observational Study for Model Development and Retrospective Study for Validation of Developed Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia&#xD;
      induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian&#xD;
      cancer and to validate this model.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk prediction model for grade 3-4 chemotherapy induced neutropenia</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The association between mannose-binding lectin 2 gene SNP and neutropenia</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Epithelial Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Training cohort</arm_group_label>
    <description>This cohort is a prospective cohort to develop a risk prediction model. This cohort include patients who underwent staging operation or debulking operation for epithelial ovarian cancer and are planned to receive ajuvant chemotherapy with paclitaxel/carboplatin up to 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validation cohort</arm_group_label>
    <description>This is a retrospective cohort for validation of a risk prediction model developed using training cohort.&#xD;
This is consisted with 600 patients with epithelial ovarian cancer who received adjuvant chemotherapy with paclitaxel/carboplatin after staging operation or debulking operation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Training cohort (prospective cohort): Patients with epithelial ovarian cancer who underwent&#xD;
        staging operation or debulking surgery at university hospital and who are planned to&#xD;
        receive adjuvant chemotherapy with paclitaxel and carboplatin.&#xD;
&#xD;
        Validation cohort (retrospective cohort): Patients with epithelial ovarian cancer who&#xD;
        received adjuvant chemotherapy with paclitaxel and carboplatin after staging operation or&#xD;
        debulking operation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with FIGO stage I-IV epithelial ovarian cancer after staging or debulking&#xD;
             surgery&#xD;
&#xD;
          -  Patients who is planned to receive (prospective cohort) ro who received (retrospective&#xD;
             cohort) adjuvant chemotherapy with paclitaxel and carboplatin&#xD;
&#xD;
          -  Patients who have signed approved informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled medical disease&#xD;
&#xD;
          -  Active infectious disease&#xD;
&#xD;
          -  Previous pelvic radiation therapy&#xD;
&#xD;
          -  Previous chemotherapy (prospective cohort)&#xD;
&#xD;
          -  Patients with disease which can cause neutropenia&#xD;
&#xD;
          -  Patients who will receive other targeted therapy or immunotherapy during adjuvant&#xD;
             therapy (prospective cohort).&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong-Yeol Park, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeong-Yeol Park, M.D., Ph.D.</last_name>
    <phone>82-2-3010-3646</phone>
    <email>catgut1-0@hanmail.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeong-Yeol Park, M.D., Ph.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 27, 2017</last_update_submitted>
  <last_update_submitted_qc>May 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Jeong-Yeol Park</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Neutropenia</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Carboplatin</keyword>
  <keyword>Epithelial ovarian cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Neutropenia</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/NCT01680575
org study id: NEPACA-OVCA
nct id: NCT01680575
lead sponsor: 
has dmc: No
To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia
      induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian
      cancer and to validate this model.
observational model: Cohort
time perspective: Prospective
measure: Risk prediction model for grade 3-4 chemotherapy induced neutropenia
time frame: 1 year
measure: The association between mannose-binding lectin 2 gene SNP and neutropenia
time frame: 1 year
arm group label: Training cohort
description: This cohort is a prospective cohort to develop a risk prediction model. This cohort include patients who underwent staging operation or debulking operation for epithelial ovarian cancer and are planned to receive ajuvant chemotherapy with paclitaxel/carboplatin up to 6 cycles.
arm group label: Validation cohort
description: This is a retrospective cohort for validation of a risk prediction model developed using training cohort.
This is consisted with 600 patients with epithelial ovarian cancer who received adjuvant chemotherapy with paclitaxel/carboplatin after staging operation or debulking operation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jeong-Yeol Park, M.D., Ph.D.
role: Principal Investigator
affiliation: Asan Medical Center
last name: Jeong-Yeol Park, M.D., Ph.D.
phone: 82-2-3010-3646
email: catgut1-0@hanmail.net
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Jeong-Yeol Park
investigator title: Clinical Assistant Professor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Neutropenia