<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/NCT03253107</url>
  </required_header>
  <id_info>
    <org_study_id>KNUMC 2015-10-002-004</org_study_id>
    <nct_id>NCT03253107</nct_id>
  </id_info>
  <brief_title>Predicting Biomarker of Gastric Cancer Chemotherapy Response</brief_title>
  <official_title>Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      -  discovery and validation of biomarker predicting gastric cancer chemotherapy response&#xD;
&#xD;
             -  Analysis for expression level of mRNA using Next generation sequencing in gastric&#xD;
                cancer tissue by chemotherapy response&#xD;
&#xD;
             -  Analysis for expression level of miRNA using Next generation sequencing in gastric&#xD;
                cancer tissue and blood by chemotherapy response&#xD;
&#xD;
             -  Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort&#xD;
&#xD;
        -  Biological biomarkers-clinical factor combined prediction model of gastric cancer&#xD;
           chemotherapy response&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  discovery and validation of biomarker predicting gastric cancer chemotherapy response&#xD;
&#xD;
             -  Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by&#xD;
                chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B)&#xD;
                study group Palliative chemotherapy (inoperable patients)&#xD;
&#xD;
                  -  institutional primary Chemotherapy regimen (XP or Xelox)&#xD;
&#xD;
                       1. response group&#xD;
&#xD;
                       2. progression group&#xD;
&#xD;
                          Post-OP adjuvant chemotherapy&#xD;
&#xD;
                  -  institutional primary Chemotherapy regimen&#xD;
&#xD;
                       1. complete response group&#xD;
&#xD;
                       2. non-responder group&#xD;
&#xD;
                       1. and 2) groups: age, sex, regimen matched&#xD;
&#xD;
             -  Analysis for expression level of miRNA using Next generation sequencing in gastric&#xD;
                cancer tissue and blood by chemotherapy response (A) method of mRNA expression&#xD;
                measurement: RNA sequencing (B) study group&#xD;
&#xD;
                  -  the same patients in mRNA sequencing&#xD;
&#xD;
             -  Validation of mRNA and miRNA in multiple independent cohort method of measurement&#xD;
                of RNA expression: qRT-PCR&#xD;
&#xD;
        -  Biological biomarkers-clinical factor combined prediction model of gastric cancer&#xD;
           chemotherapy response combination of biologic biomarker and clinical factors to predict&#xD;
           the chemotherapy response in gastric cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2015</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Discovery of predicting bio-markers for gastric cancer chemotherapy response</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Combination prediction model for adjuvant chemotherapy response in gastric cancer</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combination prediction model for palliative chemotherapy response in gastric cancer</measure>
    <time_frame>up to 3 years</time_frame>
    <description>Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Chemotherapy Effect</condition>
  <condition>Predictive Cancer Model</condition>
  <arm_group>
    <arm_group_label>responder in palliative chemotherapy</arm_group_label>
    <description>After initial chemotherapy, responder (complete remission, partial remission)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-responder in palliative chemotherapy</arm_group_label>
    <description>After initial chemotherapy, disease progression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>responder in adjuvant chemotherapy</arm_group_label>
    <description>complete cure and no recurrence at least 1 year after treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-responder in adjuvant chemotherapy</arm_group_label>
    <description>non-complete cure or recurrence within 1 year after treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Institutinal standard chemotherapy as first line&#xD;
: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin</description>
    <arm_group_label>non-responder in adjuvant chemotherapy</arm_group_label>
    <arm_group_label>non-responder in palliative chemotherapy</arm_group_label>
    <arm_group_label>responder in adjuvant chemotherapy</arm_group_label>
    <arm_group_label>responder in palliative chemotherapy</arm_group_label>
    <other_name>XP or Xelox +/- Herceptin</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      RNA from gastric tissue and blood&#xD;
&#xD;
      DNA from blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        &lt;Next generation sequencing analysis&gt; (A) palliative chemotherapy&#xD;
&#xD;
          1. responder (n=15)&#xD;
&#xD;
          2. progression (n=15)&#xD;
&#xD;
        (B) adjuvant chemotherpay&#xD;
&#xD;
          1. complete response (n=15)&#xD;
&#xD;
          2. non-responder (n=15)&#xD;
&#xD;
        &lt;qRT-PCR analysis&gt; (Experimental set) (A) palliative chemotherapy&#xD;
&#xD;
          1. responder (n=60)&#xD;
&#xD;
          2. progression (n=60)&#xD;
&#xD;
        (B) adjuvant chemotherpay&#xD;
&#xD;
          1. complete responder (n=60)&#xD;
&#xD;
          2. non-responder (n=60)&#xD;
&#xD;
        (Validation set) (A) palliative chemotherapy&#xD;
&#xD;
          1. responder (n=40)&#xD;
&#xD;
          2. progression (n=40)&#xD;
&#xD;
        (B) adjuvant chemotherpay&#xD;
&#xD;
          1. complete responder (n=40)&#xD;
&#xD;
          2. non-responder (n=40)&#xD;
&#xD;
        1. and 2) groups: age, sex, regimen matched. Therefore this study will be nested&#xD;
        case-control study. We will enroll 800 patients and then we will matched age, sex, and&#xD;
        regimen in each group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy&#xD;
&#xD;
          -  patients who agreed this study and voluntarily assigned the informed consents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who refused the study.&#xD;
&#xD;
          -  patients who have other cancers&#xD;
&#xD;
          -  heavy alcoholics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Su Youn Nam, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Su Youn Nam, MD, PhD</last_name>
    <phone>82-53-200-2610</phone>
    <email>nam20131114@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kyungpook National University Medical Canter</name>
      <address>
        <city>Daegu</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Su Youn Y Nam, MD, PhD</last_name>
      <phone>82-53-200-2610</phone>
      <email>nam20131114@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 8, 2021</last_update_submitted>
  <last_update_submitted_qc>August 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Chilgok Hospital</investigator_affiliation>
    <investigator_full_name>Su Youn Nam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>RNA sequencing</keyword>
  <keyword>chemotherapy response</keyword>
  <keyword>miRNA sequencing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03253107
org study id: KNUMC 2015-10-002-004
nct id: NCT03253107
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
-  discovery and validation of biomarker predicting gastric cancer chemotherapy response

             -  Analysis for expression level of mRNA using Next generation sequencing in gastric
                cancer tissue by chemotherapy response

             -  Analysis for expression level of miRNA using Next generation sequencing in gastric
                cancer tissue and blood by chemotherapy response

             -  Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort

        -  Biological biomarkers-clinical factor combined prediction model of gastric cancer
           chemotherapy response
-  discovery and validation of biomarker predicting gastric cancer chemotherapy response

             -  Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by
                chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B)
                study group Palliative chemotherapy (inoperable patients)

                  -  institutional primary Chemotherapy regimen (XP or Xelox)

                       1. response group

                       2. progression group

                          Post-OP adjuvant chemotherapy

                  -  institutional primary Chemotherapy regimen

                       1. complete response group

                       2. non-responder group

                       1. and 2) groups: age, sex, regimen matched

             -  Analysis for expression level of miRNA using Next generation sequencing in gastric
                cancer tissue and blood by chemotherapy response (A) method of mRNA expression
                measurement: RNA sequencing (B) study group

                  -  the same patients in mRNA sequencing

             -  Validation of mRNA and miRNA in multiple independent cohort method of measurement
                of RNA expression: qRT-PCR

        -  Biological biomarkers-clinical factor combined prediction model of gastric cancer
           chemotherapy response combination of biologic biomarker and clinical factors to predict
           the chemotherapy response in gastric cancer
observational model: Case-Control
time perspective: Prospective
measure: Discovery of predicting bio-markers for gastric cancer chemotherapy response
time frame: up to 36 months
description: Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR
measure: Combination prediction model for adjuvant chemotherapy response in gastric cancer
time frame: up to 5 years
description: Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer
measure: Combination prediction model for palliative chemotherapy response in gastric cancer
time frame: up to 3 years
description: Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer
arm group label: responder in palliative chemotherapy
description: After initial chemotherapy, responder (complete remission, partial remission)
arm group label: non-responder in palliative chemotherapy
description: After initial chemotherapy, disease progression
arm group label: responder in adjuvant chemotherapy
description: complete cure and no recurrence at least 1 year after treatment
arm group label: non-responder in adjuvant chemotherapy
description: non-complete cure or recurrence within 1 year after treatment
intervention type: Drug
intervention name: Chemotherapy
description: Institutinal standard chemotherapy as first line
: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin
arm group label: non-responder in adjuvant chemotherapy
arm group label: non-responder in palliative chemotherapy
arm group label: responder in adjuvant chemotherapy
arm group label: responder in palliative chemotherapy
other name: XP or Xelox +/- Herceptin
RNA from gastric tissue and blood

      DNA from blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Su Youn Nam, MD, PhD
role: Principal Investigator
affiliation: Kyungpook National University Medical Center
last name: Su Youn Nam, MD, PhD
phone: 82-53-200-2610
email: nam20131114@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Chilgok Hospital
investigator full name: Su Youn Nam
investigator title: Professor
mesh term: Stomach Neoplasms
mesh term: Trastuzumab
sharing ipd: Undecided