<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/NCT03772197</url>
  </required_header>
  <id_info>
    <org_study_id>RI-002</org_study_id>
    <nct_id>NCT03772197</nct_id>
  </id_info>
  <brief_title>Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)</brief_title>
  <official_title>Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amwise Diagnostics Pte. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amwise Diagnostics Pte. Ltd.</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>
      A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model,&#xD;
      has been developed for early-stage breast cancer (EBC). In this study, Investigators compared&#xD;
      the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for&#xD;
      any recurrence risk type.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With improved diagnosis, breast cancer can now be detected at early stages, thus improving&#xD;
      survival rates. However, overtreatment is common; considering that the risk of recurrence is&#xD;
      low, patients may suffer from side effects without receiving the full benefits of adjuvant&#xD;
      therapies.&#xD;
&#xD;
      To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests&#xD;
      for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict®&#xD;
      assay kits, are frequently utilized. These multigene panels were development based on&#xD;
      Caucasian populations, and may not suitable to Asian population due to the differences in the&#xD;
      incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil&#xD;
      this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese&#xD;
      breast cancer patients was developed&#xD;
&#xD;
      In the current study, investigators combined clinical variables and genetic information to&#xD;
      generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on&#xD;
      a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen&#xD;
      receptor status, lymphovascular invasion, tumor grading).&#xD;
&#xD;
      By using tissues that have been tested with ODx, in this study, investigators evaluated the&#xD;
      performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a&#xD;
      cohort of patients from Taiwan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 18, 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>The locoregional recurrence (LRR) rate, within 5 years after surgery.</measure>
    <time_frame>5 years</time_frame>
    <description>LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The distant recurrence(DR) rate, within 5 years after surgery.</measure>
    <time_frame>5 years</time_frame>
    <description>DR risk calculated by 18-GC of breast cancer patients would be classified into high risk</description>
  </primary_outcome>
  <enrollment type="Actual">138</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Recurrence</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study is a local validation and multi-center study. A total of 118 early-srage breast&#xD;
        cancer (EBC) patients were included in this head-to-head comparison study, including 42,&#xD;
        15, and 81 patients treated between 2010 and 2016 at McKay Memorial Hospital, Koo&#xD;
        Foundation Sun Yat-Sen Cancer Center, and National Taiwan University Hospital,&#xD;
        respectively, in Taiwan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who have performed (Oncotype Dx) genetic testing methods before June 30,&#xD;
             2017.&#xD;
&#xD;
          2. Surgery (mastectomy or breast preservation) as the first treatment.&#xD;
&#xD;
          3. ER or PR IHC positive&#xD;
&#xD;
          4. HER2 negative&#xD;
&#xD;
          5. N0-N1 patient&#xD;
&#xD;
          6. Available with FFPE tumor tissue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. T3-T4 or N2-N3&#xD;
&#xD;
          2. With distant metastasis before surgery&#xD;
&#xD;
          3. Preoperative chemotherapy / radiotherapy&#xD;
&#xD;
          4. Insufficient FFPE tumor samples&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Skye Cheng</last_name>
    <role>Principal Investigator</role>
    <affiliation>AMWISE DIAGNOSTICS PTE. LDT.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amwise</name>
      <address>
        <city>Taipei</city>
        <zip>106</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Distant recurrence</keyword>
  <keyword>NanoString</keyword>
  <keyword>Gene-expression profiling</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Locoreginal recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Recurrence</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/NCT03772197
org study id: RI-002
nct id: NCT03772197
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model,
      has been developed for early-stage breast cancer (EBC). In this study, Investigators compared
      the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for
      any recurrence risk type.
With improved diagnosis, breast cancer can now be detected at early stages, thus improving
      survival rates. However, overtreatment is common; considering that the risk of recurrence is
      low, patients may suffer from side effects without receiving the full benefits of adjuvant
      therapies.

      To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests
      for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict®
      assay kits, are frequently utilized. These multigene panels were development based on
      Caucasian populations, and may not suitable to Asian population due to the differences in the
      incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil
      this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese
      breast cancer patients was developed

      In the current study, investigators combined clinical variables and genetic information to
      generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on
      a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen
      receptor status, lymphovascular invasion, tumor grading).

      By using tissues that have been tested with ODx, in this study, investigators evaluated the
      performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a
      cohort of patients from Taiwan.
observational model: Cohort
time perspective: Retrospective
measure: The locoregional recurrence (LRR) rate, within 5 years after surgery.
time frame: 5 years
description: LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk
measure: The distant recurrence(DR) rate, within 5 years after surgery.
time frame: 5 years
description: DR risk calculated by 18-GC of breast cancer patients would be classified into high risk
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
last name: Skye Cheng
role: Principal Investigator
affiliation: AMWISE DIAGNOSTICS PTE. LDT.
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Recurrence