<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/NCT04440683</url>
  </required_header>
  <id_info>
    <org_study_id>20190701041GH</org_study_id>
    <nct_id>NCT04440683</nct_id>
  </id_info>
  <brief_title>Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development</brief_title>
  <official_title>Antler Plate on Preventing Mammary High-risk Lesions From Malignant Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jilin University</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>
      This study aims to prove whether antler disk extract can be put into clinical practice to&#xD;
      prevent breast precancerous lesions from developing into cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Through estrogen receptor antagonists, tamoxifen can reduce the risk of breast high-risk&#xD;
      disease progression to cancer, but only reduce the probability of some ER and PR positive&#xD;
      tumors, which has no preventive effect on triple negative breast cancer and HER-2 positive&#xD;
      breast cancer. In the first hospital of Jilin University, the preparations containing antler&#xD;
      ingredients have been clinically proven to be able to treat breast hyperplasia, which has&#xD;
      been proved to be able to prevent breast cancer in basic research, and antler ingredients&#xD;
      have been proved to be non-toxic and side effects in the treatment dose. This study aims to&#xD;
      prove whether antler disk extract can be put into clinical practice to prevent breast&#xD;
      precancerous lesions from developing into cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Canceration by biopsy</measure>
    <time_frame>1 year</time_frame>
    <description>Imaging suspected malignant, confirmed by pathology</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Breast Cancer Prevention</condition>
  <arm_group>
    <arm_group_label>Antler plate group</arm_group_label>
    <description>Antler plate group</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients need to have good compliance&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between the ages of 18 and 80&#xD;
&#xD;
          -  Atypical hyperplasia or / and lobular carcinoma in situ confirmed by breast histology&#xD;
&#xD;
          -  Women with breast cancer in first degree relatives&#xD;
&#xD;
          -  Patients have better compliance with a series of research-related behaviors such as&#xD;
             the upcoming comprehensive treatment and follow-up, and can understand and accept the&#xD;
             research process of this study, and sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases&#xD;
&#xD;
          -  Patients not suitable for this study judged by researchers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aiping Shi, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Di Wu, Doctor</last_name>
    <phone>0086-13504331975</phone>
    <email>w2000mail@sohu.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hongyao Jia, Master</last_name>
    <phone>0086-1580430156</phone>
    <email>52272435@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aiping Shi, Doctor</last_name>
      <phone>0086-13364308696</phone>
      <email>13364308696@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhimin Fan, Doctor</last_name>
      <phone>0086-13756661286</phone>
      <email>fanzhimn@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Di Wu, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hongyao Jia, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xin Guan, Master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zhimin Fan, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jilin University</investigator_affiliation>
    <investigator_full_name>Aiping Shi</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <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/NCT04440683
org study id: 20190701041GH
nct id: NCT04440683
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to prove whether antler disk extract can be put into clinical practice to
      prevent breast precancerous lesions from developing into cancer.
Through estrogen receptor antagonists, tamoxifen can reduce the risk of breast high-risk
      disease progression to cancer, but only reduce the probability of some ER and PR positive
      tumors, which has no preventive effect on triple negative breast cancer and HER-2 positive
      breast cancer. In the first hospital of Jilin University, the preparations containing antler
      ingredients have been clinically proven to be able to treat breast hyperplasia, which has
      been proved to be able to prevent breast cancer in basic research, and antler ingredients
      have been proved to be non-toxic and side effects in the treatment dose. This study aims to
      prove whether antler disk extract can be put into clinical practice to prevent breast
      precancerous lesions from developing into cancer.
observational model: Cohort
time perspective: Prospective
measure: Canceration by biopsy
time frame: 1 year
description: Imaging suspected malignant, confirmed by pathology
arm group label: Antler plate group
description: Antler plate group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Aiping Shi, Doctor
role: Principal Investigator
affiliation: The First Hospital of Jilin University
last name: Di Wu, Doctor
phone: 0086-13504331975
email: w2000mail@sohu.com
last name: Hongyao Jia, Master
phone: 0086-1580430156
email: 52272435@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jilin University
investigator full name: Aiping Shi
investigator title: professor
sharing ipd: No