<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/NCT04487717</url>
  </required_header>
  <id_info>
    <org_study_id>NM-CTP-05</org_study_id>
    <nct_id>NCT04487717</nct_id>
  </id_info>
  <brief_title>Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer</brief_title>
  <acronym>PREDICT</acronym>
  <official_title>Prospective Assessment of nProfiler® 1 on Prognosis and Chemotherapy Response for Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novomics. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novomics. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response&#xD;
      for resectable gastric cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background: According to Global Cancer Statistics of International Agency for Research&#xD;
           on Cancer under World Health Organization, stomach cancer is the fifth most common&#xD;
           cancer as there were over 1 million new cases in 2018 and the third leading cause of&#xD;
           cancer death by 783,000 people are estimated to die of stomach cancer. In Korea, gastric&#xD;
           cancer is the most frequent cancer in 13.3% of all cancer cases by the report of Korea&#xD;
           Central Cancer Registry in 2018. Since 2010, adjuvant chemotherapy with advanced gastric&#xD;
           cancer stage 2 and stage 3 patients following gastrectomy has become a standard&#xD;
           treatment through clinical validation of increasing the patient's survival rate.&#xD;
           However, even in the second and third stages of the same stomach cancer, the biological&#xD;
           properties may be different.&#xD;
&#xD;
        2. Purpose:&#xD;
&#xD;
           The nProfiler® 1 Stomach Cancer Assay is a molecular diagnostic test to predict the&#xD;
           prognosis for patients with stage Ⅱ-Ⅲ advanced gastric cancer. This study will evaluate&#xD;
           the clinical utility of nProfiler® 1 Stomach Cancer Assay by recruiting subjects from&#xD;
           multi centers and observing the 5-year survival rates of Low risk, Intermediate risk,&#xD;
           High risk according to gastric cancer prognostic molecular diagnostic test.&#xD;
&#xD;
        3. Study Procedure:&#xD;
&#xD;
             -  Obtaining of informed consent form&#xD;
&#xD;
             -  Review of provider's eligibility/ Sample preparation and delivery&#xD;
&#xD;
             -  Sample criteria evaluation&#xD;
&#xD;
             -  Subject enrollment&#xD;
&#xD;
             -  Gastric cancer prognostic prediction molecular diagnostic test&#xD;
&#xD;
             -  Prognostic group result report&#xD;
&#xD;
             -  5-yr survival follow-up&#xD;
&#xD;
             -  Statistical analysis&#xD;
&#xD;
        4. Outcome Measures:&#xD;
&#xD;
      The following efficacy outcome measures will be assessed:&#xD;
&#xD;
        -  Primary efficacy outcome measure&#xD;
&#xD;
           :High risk and low risk group's 5-yr Overall Survival(OS) rate&#xD;
&#xD;
        -  Secondary efficacy outcome measure&#xD;
&#xD;
             -  High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate&#xD;
&#xD;
             -  Intermediate risk group's 5-yr OS and 3-yr DFS rate&#xD;
&#xD;
             -  Subgroup analysis : Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr&#xD;
                DFS rate)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">January 29, 2027</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2026</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>Prognostic group's 5-yr Overall Survival(OS) rate</measure>
    <time_frame>5 years after last registered patient</time_frame>
    <description>High risk and low risk group's 5-yr Overall Survival(OS) rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prognostic group's 3-yr Disease Free Survival(DFS) rate</measure>
    <time_frame>3 years after last registered patient</time_frame>
    <description>High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate Intermediate risk group's 5-yr Os and 3-yr DFS rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subgroup analysis</measure>
    <time_frame>3, 5 years after last registered patient</time_frame>
    <description>Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">688</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Low risk</arm_group_label>
    <description>good prognosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate risk</arm_group_label>
    <description>moderate prognosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High risk</arm_group_label>
    <description>poor prognosis</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        19 years or older patients with stage II, III gastric adenocarcinoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sample providers criteria&#xD;
&#xD;
               -  Male and female adult patients aged 19 years or over&#xD;
&#xD;
               -  Patients with histologically confirmed gastric adenocarcinoma&#xD;
&#xD;
               -  Patients with histologically confirmed stage Ⅱ or Ⅲ&#xD;
&#xD;
               -  Patients who have undergone radical gastrectomy&#xD;
&#xD;
               -  Patients who have not received neoadjuvant chemotherapy and radiotherapy&#xD;
&#xD;
               -  Patients who have undergone a radical gastrectomy and who show no evidence of&#xD;
                  residual tumors as observed with the unaided eye or through a microscope&#xD;
&#xD;
               -  Patients who have signed a written consent of the study and signed a human&#xD;
                  derived research agreement (Form 34)&#xD;
&#xD;
          2. Sample criteria&#xD;
&#xD;
               -  The formalin-fixed paraffin-embedded (FFPE) tumor specimens in storage have a&#xD;
                  tumor amount of at least 20% and therefore can be tested.&#xD;
&#xD;
               -  The quantity (not less than 400ng) and quality (A260/280 of not less than 1.8) of&#xD;
                  RNA are sufficient for analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sample providers criteria&#xD;
&#xD;
               -  Male and female patients aged less than 19 years&#xD;
&#xD;
               -  Patients with histologically not confirmed gastric adenocarcinoma&#xD;
&#xD;
               -  Patients with histologically confirmed stage Ⅰ or Ⅳ&#xD;
&#xD;
               -  Patients who have not undergone radical gastrectomy&#xD;
&#xD;
               -  Patients who have received neoadjuvant chemotherapy or radiotherapy&#xD;
&#xD;
               -  Patients with distant or peritoneal metastasis at the time of surgery or residual&#xD;
                  tumors after surgery&#xD;
&#xD;
               -  Patients who have not signed the study's written consent and human derived&#xD;
                  research agreement (Form 34)&#xD;
&#xD;
          2. Sample criteria&#xD;
&#xD;
               -  The FFPE tumor specimens in storage have a tumor amount of less than 20% and&#xD;
                  therefore cannot be tested&#xD;
&#xD;
               -  The quantity and quality of RNA are not sufficient for analysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-Woo Kim, MD., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jungmin Park, Ph.D.</last_name>
    <phone>82-2-2068-3700</phone>
    <phone_ext>6859</phone_ext>
    <email>jungmin.park@novomics.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Novomics</name>
      <address>
        <city>Seoul</city>
        <zip>07217</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jungmin Park, Ph.D.</last_name>
      <phone>82-2-2068-3700</phone>
      <email>jungmin.park@novomics.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04487717
org study id: NM-CTP-05
nct id: NCT04487717
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective assessment of nProfiler® 1 predictive test on prognosis and chemotherapy response
      for resectable gastric cancer
1. Background: According to Global Cancer Statistics of International Agency for Research
           on Cancer under World Health Organization, stomach cancer is the fifth most common
           cancer as there were over 1 million new cases in 2018 and the third leading cause of
           cancer death by 783,000 people are estimated to die of stomach cancer. In Korea, gastric
           cancer is the most frequent cancer in 13.3% of all cancer cases by the report of Korea
           Central Cancer Registry in 2018. Since 2010, adjuvant chemotherapy with advanced gastric
           cancer stage 2 and stage 3 patients following gastrectomy has become a standard
           treatment through clinical validation of increasing the patient's survival rate.
           However, even in the second and third stages of the same stomach cancer, the biological
           properties may be different.

        2. Purpose:

           The nProfiler® 1 Stomach Cancer Assay is a molecular diagnostic test to predict the
           prognosis for patients with stage Ⅱ-Ⅲ advanced gastric cancer. This study will evaluate
           the clinical utility of nProfiler® 1 Stomach Cancer Assay by recruiting subjects from
           multi centers and observing the 5-year survival rates of Low risk, Intermediate risk,
           High risk according to gastric cancer prognostic molecular diagnostic test.

        3. Study Procedure:

             -  Obtaining of informed consent form

             -  Review of provider's eligibility/ Sample preparation and delivery

             -  Sample criteria evaluation

             -  Subject enrollment

             -  Gastric cancer prognostic prediction molecular diagnostic test

             -  Prognostic group result report

             -  5-yr survival follow-up

             -  Statistical analysis

        4. Outcome Measures:

      The following efficacy outcome measures will be assessed:

        -  Primary efficacy outcome measure

           :High risk and low risk group's 5-yr Overall Survival(OS) rate

        -  Secondary efficacy outcome measure

             -  High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate

             -  Intermediate risk group's 5-yr OS and 3-yr DFS rate

             -  Subgroup analysis : Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr
                DFS rate)
observational model: Cohort
time perspective: Prospective
measure: Prognostic group's 5-yr Overall Survival(OS) rate
time frame: 5 years after last registered patient
description: High risk and low risk group's 5-yr Overall Survival(OS) rate
measure: Prognostic group's 3-yr Disease Free Survival(DFS) rate
time frame: 3 years after last registered patient
description: High risk and Low risk group's 3-yr Disease Free Survival(DFS) rate Intermediate risk group's 5-yr Os and 3-yr DFS rate
measure: Subgroup analysis
time frame: 3, 5 years after last registered patient
description: Adjuvant chemotherapy benefit of Low risk (5-yr OS rate, 3 yr DFS rate)
arm group label: Low risk
description: good prognosis
arm group label: Intermediate risk
description: moderate prognosis
arm group label: High risk
description: poor prognosis
tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Young-Woo Kim, MD., Ph.D.
role: Principal Investigator
affiliation: National Cancer Center
last name: Jungmin Park, Ph.D.
phone: 82-2-2068-3700
phone ext: 6859
email: jungmin.park@novomics.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stomach Neoplasms
sharing ipd: No