<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/NCT01707862</url>
  </required_header>
  <id_info>
    <org_study_id>GHBeijing-20121012</org_study_id>
    <nct_id>NCT01707862</nct_id>
  </id_info>
  <brief_title>Surgery for Intravenous Leiomyomatosis</brief_title>
  <acronym>SIVL</acronym>
  <official_title>Surgical Management of Intravenous Leiomyomatosis With Intracardiac Extension: Our Experience and Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Li Yang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>General Hospital of Beijing PLA Military Region</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle&#xD;
      tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least&#xD;
      70 cases. Most are individual case reports. Surgical experience is not much. However,&#xD;
      different opinion of surgical strategies remain controversial. The purpose of this report is&#xD;
      to describe our experience of surgical management for the IVL with intracardiac extension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients underwent surgical management. Clinical data were obtained from medical reports.&#xD;
      Following-up was made through email and telephone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 1997</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>
  <enrollment type="Actual">6</enrollment>
  <condition>Leiomyomatosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        From March 1997 to June 2011, 6 women patients were admitted to our hospital with&#xD;
        intravenous leiomyomatosis with intracardiac extension.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 18 years.&#xD;
&#xD;
          -  Tumor markers were all within normal limits.&#xD;
&#xD;
          -  Patients underwent surgical management.&#xD;
&#xD;
          -  Patients were followed-up for more than 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Tumor markers were all within abnormal limits&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Genetal Hospital Beijing Military Region, First class</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Cardiovascular Disease</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Cardiovascular Disease</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>General Hospital of Beijing PLA Military Region</investigator_affiliation>
    <investigator_full_name>Li Yang</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Intravenous leiomyomatosis</keyword>
  <keyword>Surgery</keyword>
  <keyword>Smooth muscle tumor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyomatosis</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/NCT01707862
org study id: GHBeijing-20121012
nct id: NCT01707862
lead sponsor: 
has dmc: Yes
Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle
      tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least
      70 cases. Most are individual case reports. Surgical experience is not much. However,
      different opinion of surgical strategies remain controversial. The purpose of this report is
      to describe our experience of surgical management for the IVL with intracardiac extension.
All patients underwent surgical management. Clinical data were obtained from medical reports.
      Following-up was made through email and telephone.
observational model: Cohort
time perspective: Retrospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Genetal Hospital Beijing Military Region, First class
role: Principal Investigator
affiliation: Institute of Cardiovascular Disease
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: General Hospital of Beijing PLA Military Region
investigator full name: Li Yang
investigator title: Doctor
mesh term: Leiomyomatosis