<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/NCT02263846</url>
  </required_header>
  <id_info>
    <org_study_id>CBCSG008</org_study_id>
    <nct_id>NCT02263846</nct_id>
  </id_info>
  <brief_title>Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer</brief_title>
  <official_title>Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital to Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese Anti-Cancer Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Affiliated Hospital to Academy of Military Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to investigate sex hormones levels of Chinese patients with invasive breast&#xD;
      cancer.The aim is to analyze biochemical monitoring results of premenopausal and&#xD;
      postmenopausal patients to facilitate determination of menopausal status and propose clinical&#xD;
      application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Follicle stimulating hormone (FSH), estradiol (E2) and luteinizing hormone (LH) can serve as&#xD;
      indicators in the determination of menopausal status. NCCN clinical practice guidelines for&#xD;
      breast cancer recommend detecting the levels of FSH and E2 for amenorrhea patients less than&#xD;
      60 years of age. But the detection method and the corresponding reference ranges indicating&#xD;
      postmenopausal status are not mentioned. In addition, the reference limits vary a lot among&#xD;
      different equipments and methods when it comes to diagnosis of menopause, thus it is&#xD;
      difficult to set universal criteria. So in this study, four widely used methods and&#xD;
      instruments in China are used to detect plasma levels of FSH, E2 and LN of premenopausal and&#xD;
      postmenopausal patients. Instruments and methods must be one of the following four&#xD;
      categories: microparticle chemiluminescent(Beckman),acridinium ester chemiluminescence&#xD;
      (Siemens),acridinium ester chemiluminescence (Abbott) and electrochemiluminescence（Roche）.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The capability of sex hormones to discriminate between pre- and postmenopausal women with invasive breast cancer measured by four widely used methods and instruments in China.</measure>
    <time_frame>Two years</time_frame>
    <description>Distribution characteristics of three hormones in pre- and postmenopausal patients are described with Kernel density estimation. Their discrimination capabilities are evaluated with operating characteristics (ROC) curve.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1183</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Postmenopausal group</arm_group_label>
    <description>Patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Premenopausal group</arm_group_label>
    <description>Patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone analogue therapy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese women with invasive breast cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Invasive breast cancer patients confirmed through pathology.&#xD;
&#xD;
          -  For postmenopausal group: patients at the age ≥ 60 years with more than one year of&#xD;
             menopause, or patients having undergone bilateral oophorectomy.&#xD;
&#xD;
          -  For premenopausal group: patients with regular menses during recent 3 months and&#xD;
             having never received luteinizing hormone-releasing hormone (LHRH) analogue therapy.&#xD;
&#xD;
          -  Patients who meet the above criteria can be enrolled whether they have received&#xD;
             anti-cancer treatment or not.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients less than 60 years old who are amenorrhoeic but have not received bilateral&#xD;
             oophorectomy or medical castration.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santai Song</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital to Academy of Military Medical Sciences</affiliation>
  </overall_official>
  <reference>
    <citation>Smith IE, Dowsett M, Yap YS, Walsh G, Lonning PE, Santen RJ, Hayes D. Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: caution and suggested guidelines. J Clin Oncol. 2006 Jun 1;24(16):2444-7. doi: 10.1200/JCO.2005.05.3694.</citation>
    <PMID>16735701</PMID>
  </reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>April 9, 2015</last_update_submitted>
  <last_update_submitted_qc>April 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Menopause</keyword>
  <keyword>Estradiol</keyword>
  <keyword>Follicle stimulating hormone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT02263846
org study id: CBCSG008
nct id: NCT02263846
lead sponsor: 
collaborator: 
has dmc: No
This study is to investigate sex hormones levels of Chinese patients with invasive breast
      cancer.The aim is to analyze biochemical monitoring results of premenopausal and
      postmenopausal patients to facilitate determination of menopausal status and propose clinical
      application.
Follicle stimulating hormone (FSH), estradiol (E2) and luteinizing hormone (LH) can serve as
      indicators in the determination of menopausal status. NCCN clinical practice guidelines for
      breast cancer recommend detecting the levels of FSH and E2 for amenorrhea patients less than
      60 years of age. But the detection method and the corresponding reference ranges indicating
      postmenopausal status are not mentioned. In addition, the reference limits vary a lot among
      different equipments and methods when it comes to diagnosis of menopause, thus it is
      difficult to set universal criteria. So in this study, four widely used methods and
      instruments in China are used to detect plasma levels of FSH, E2 and LN of premenopausal and
      postmenopausal patients. Instruments and methods must be one of the following four
      categories: microparticle chemiluminescent(Beckman),acridinium ester chemiluminescence
      (Siemens),acridinium ester chemiluminescence (Abbott) and electrochemiluminescence（Roche）.
observational model: Case-Only
time perspective: Prospective
measure: The capability of sex hormones to discriminate between pre- and postmenopausal women with invasive breast cancer measured by four widely used methods and instruments in China.
time frame: Two years
description: Distribution characteristics of three hormones in pre- and postmenopausal patients are described with Kernel density estimation. Their discrimination capabilities are evaluated with operating characteristics (ROC) curve.
arm group label: Postmenopausal group
description: Patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.
arm group label: Premenopausal group
description: Patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone analogue therapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Santai Song
role: Principal Investigator
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
citation: Smith IE, Dowsett M, Yap YS, Walsh G, Lonning PE, Santen RJ, Hayes D. Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: caution and suggested guidelines. J Clin Oncol. 2006 Jun 1;24(16):2444-7. doi: 10.1200/JCO.2005.05.3694.
PMID: 16735701
responsible party type: Sponsor
mesh term: Breast Neoplasms