<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/NCT03841266</url>
  </required_header>
  <id_info>
    <org_study_id>KY2019</org_study_id>
    <nct_id>NCT03841266</nct_id>
  </id_info>
  <brief_title>Recurrence Risk Evaluation by 21-gene Detection</brief_title>
  <official_title>Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer patients with early breast cancer were enrolled according to the inclusion&#xD;
      criteria. Baseline characteristics were recorded from medical record system. Recurrence score&#xD;
      were obtained by 21-gene detection kits from different biological companies. Relationship&#xD;
      between recurrence score and the prognosis was explored. Meanwhile, the investigators&#xD;
      analyzed the consistency of the results obtained from various 21-gene test kits and&#xD;
      immunohistochemistry detection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 20, 2019</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>correlation analysis</measure>
    <time_frame>Janyary 1, 2019-December 31, 2019</time_frame>
    <description>x2 value and P value of chi-square test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>consistency analysis</measure>
    <time_frame>Janyary 1, 2019-December 31, 2019</time_frame>
    <description>kappa value, P value of consistency analysis</description>
  </secondary_outcome>
  <enrollment type="Actual">220</enrollment>
  <condition>Relationship and Consistency Analysis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>recurrence risk evaluation</intervention_name>
    <description>Recurrence score were obtained by 21-gene detection kits from different biological companies. The expression of ER, PR, and Her-2 were also detected by IHC.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Breast cancer patients with early breast cancer were enrolled according to the inclusion&#xD;
        criteria. Baseline characteristics were recorded from medical record system. Recurrence&#xD;
        score were obtained by 21-gene detection kits from different biological companies.&#xD;
        Relationship between recurrence score and the prognosis was explored. Meanwhile, we&#xD;
        analyzed the consistency of the results obtained from various 21-gene test kits and&#xD;
        immunohistochemistry detection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. breast cancer in stage I-III, tumor size&gt;0.5cm&#xD;
&#xD;
          2. lymph nodes negative&#xD;
&#xD;
          3. hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+）&#xD;
&#xD;
          4. HER2 negative（IHC 0 or +， FISH negative）&#xD;
&#xD;
          5. receive endocrine therapy only&#xD;
&#xD;
          6. enough FFPE samples within 10 years（3~6 10μm ）&#xD;
&#xD;
          7. patients with integrated medical records&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Tumor cells &lt;5%&#xD;
&#xD;
          2. Isolated RNA&lt;500ng&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Xijing hoapital</name>
      <address>
        <city>Xi'an</city>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>LiNanlin,Ph.D, Chief Physician,Clinical Professor</investigator_full_name>
    <investigator_title>Professor, Thyroid breast and vascular surgery, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03841266
org study id: KY2019
nct id: NCT03841266
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Breast cancer patients with early breast cancer were enrolled according to the inclusion
      criteria. Baseline characteristics were recorded from medical record system. Recurrence score
      were obtained by 21-gene detection kits from different biological companies. Relationship
      between recurrence score and the prognosis was explored. Meanwhile, the investigators
      analyzed the consistency of the results obtained from various 21-gene test kits and
      immunohistochemistry detection.
observational model: Cohort
time perspective: Retrospective
measure: correlation analysis
time frame: Janyary 1, 2019-December 31, 2019
description: x2 value and P value of chi-square test
measure: consistency analysis
time frame: Janyary 1, 2019-December 31, 2019
description: kappa value, P value of consistency analysis
intervention type: Diagnostic Test
intervention name: recurrence risk evaluation
description: Recurrence score were obtained by 21-gene detection kits from different biological companies. The expression of ER, PR, and Her-2 were also detected by IHC.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: LiNanlin,Ph.D, Chief Physician,Clinical Professor
investigator title: Professor, Thyroid breast and vascular surgery, Principal Investigator
mesh term: Recurrence