<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/NCT03294343</url>
  </required_header>
  <id_info>
    <org_study_id>SOHHO</org_study_id>
    <nct_id>NCT03294343</nct_id>
  </id_info>
  <brief_title>Risk-Reducing Surgeries for Hereditary Ovarian Cancer</brief_title>
  <official_title>Risk-Reducing Surgeries of Salpingo-oophorectomy With/Without Hysterectomy for Carriers With Mutation Genes of Hereditary Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lei Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College 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>
      Based on studies of &quot;Inherited Susceptible Genes Among Epithelial Ovarian Cancer&quot;&#xD;
      (NCT03015376, clinicaltrials.gov) and &quot;Cohort Study of Universal Screening for Lynch Syndrome&#xD;
      in Chinese Patients of Endometrial Cancer&quot; (NCT03291106, clinicaltrials.gov), we provide&#xD;
      risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy&#xD;
      carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer&#xD;
      with relevant pathogenic mutations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occult cancer or precancerous lesion in histological specimen</measure>
    <time_frame>5 years</time_frame>
    <description>Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>10 years</time_frame>
    <description>Duration from surgery to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of primary peritoneal carcinoma</measure>
    <time_frame>10 years</time_frame>
    <description>Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of primary uterine cancer</measure>
    <time_frame>10 years</time_frame>
    <description>Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Hereditary Breast and Ovarian Cancer Syndrome</condition>
  <condition>Colorectal Neoplasms, Hereditary Nonpolyposis</condition>
  <condition>Ovariectomy</condition>
  <condition>Hysterectomy</condition>
  <arm_group>
    <arm_group_label>HBOCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For carriers with mutation genes of BRCA1, BRCA2 (both belonging to mutation genes of hereditary breast and ovarian cancer syndrome, HBOCS) and ATM, BRIP1, RAD51, RAD51C, and RAD51D (all belonging to mutation genes of other hereditary ovarian cancer syndrome), if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy only by laparoscopy and long-term follow-up are provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lynch syndromes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11, , if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy with hysterectomy by laparoscopy and long-term follow-up are provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Refusal to surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For carriers with any mutation genes (BRCA1, BRCA2, ATM, BRIP1, RAD51, RAD51C, RAD51D, STK11, MLH1, MSH2, MSH6, PMS2 and EPCAM) but refusal to any risk-reducing surgeries, counseling, decision-making analysis, and then long-term follow-up are provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>salpingo-oophorectomy only by laparoscopy</intervention_name>
    <description>Salpingo-oophorectomy are provided for carriers with mutation genes of BRCA1, BRCA2 (both belonging to mutation genes of hereditary breast and ovarian cancer syndrome, HBOCS) and ATM, BRIP1, RAD51, RAD51C, and RAD51D (all belonging to mutation genes of other hereditary ovarian cancer syndrome). Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.</description>
    <arm_group_label>HBOCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>salpingo-oophorectomy with hysterectomy by laparoscopy</intervention_name>
    <description>Salpingo-oophorectomy with hysterectomy are provided for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11. Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.</description>
    <arm_group_label>Lynch syndromes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up</intervention_name>
    <description>Detailed multi-disciplinary counseling, decision-making analysis and long-term follow-up are provided for carriers with any mutation genes but refusal to any risk-reducing gynecologic surgeries</description>
    <arm_group_label>Refusal to surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Carriers with known and definite mutation genes of hereditary ovarian cancer.&#xD;
&#xD;
          -  With children and without further requirement of pregnancy.&#xD;
&#xD;
          -  No less than 35 years for carriers with mutation gene of BRCA1.&#xD;
&#xD;
          -  No less than 40 years for carriers with mutation gene of BRCA2.&#xD;
&#xD;
          -  No less than 45 years for carriers with mutation genes of BRIP1, RAD51C, RAD51D and&#xD;
             RAD51.&#xD;
&#xD;
          -  No less than 50 years for carriers with mutation genes of ATM, MSH2, MLH1, SH6, PMS2,&#xD;
             EPCAM and STK11.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Without children.&#xD;
&#xD;
          -  Not reaching appreciate ages.&#xD;
&#xD;
          -  With contraindications of laparoscopy.&#xD;
&#xD;
          -  Refusal of risk-reducing surgeries.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li, MD</last_name>
    <phone>13911988831</phone>
    <phone_ext>+86</phone_ext>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>China/Beiing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei L Li, MD</last_name>
      <phone>13911988831</phone>
      <phone_ext>+86</phone_ext>
      <email>lileigh@163.com</email>
    </contact>
    <investigator>
      <last_name>Ming Wu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>December 22, 2017</last_update_submitted>
  <last_update_submitted_qc>December 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Hereditary Breast and Ovarian Cancer Syndrome</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03294343
org study id: SOHHO
nct id: NCT03294343
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Based on studies of "Inherited Susceptible Genes Among Epithelial Ovarian Cancer"
      (NCT03015376, clinicaltrials.gov) and "Cohort Study of Universal Screening for Lynch Syndrome
      in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov), we provide
      risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy
      carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer
      with relevant pathogenic mutations.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Occult cancer or precancerous lesion in histological specimen
time frame: 5 years
description: Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)
measure: Overall survival
time frame: 10 years
description: Duration from surgery to death
measure: Incidence of primary peritoneal carcinoma
time frame: 10 years
description: Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy
measure: Incidence of primary uterine cancer
time frame: 10 years
description: Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy
arm group label: HBOCS
arm group type: Experimental
description: For carriers with mutation genes of BRCA1, BRCA2 (both belonging to mutation genes of hereditary breast and ovarian cancer syndrome, HBOCS) and ATM, BRIP1, RAD51, RAD51C, and RAD51D (all belonging to mutation genes of other hereditary ovarian cancer syndrome), if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy only by laparoscopy and long-term follow-up are provided.
arm group label: Lynch syndromes
arm group type: Experimental
description: for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11, , if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy with hysterectomy by laparoscopy and long-term follow-up are provided.
arm group label: Refusal to surgery
arm group type: Other
description: For carriers with any mutation genes (BRCA1, BRCA2, ATM, BRIP1, RAD51, RAD51C, RAD51D, STK11, MLH1, MSH2, MSH6, PMS2 and EPCAM) but refusal to any risk-reducing surgeries, counseling, decision-making analysis, and then long-term follow-up are provided.
intervention type: Procedure
intervention name: salpingo-oophorectomy only by laparoscopy
description: Salpingo-oophorectomy are provided for carriers with mutation genes of BRCA1, BRCA2 (both belonging to mutation genes of hereditary breast and ovarian cancer syndrome, HBOCS) and ATM, BRIP1, RAD51, RAD51C, and RAD51D (all belonging to mutation genes of other hereditary ovarian cancer syndrome). Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.
arm group label: HBOCS
intervention type: Procedure
intervention name: salpingo-oophorectomy with hysterectomy by laparoscopy
description: Salpingo-oophorectomy with hysterectomy are provided for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11. Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.
arm group label: Lynch syndromes
intervention type: Other
intervention name: Follow-up
description: Detailed multi-disciplinary counseling, decision-making analysis and long-term follow-up are provided for carriers with any mutation genes but refusal to any risk-reducing gynecologic surgeries
arm group label: Refusal to surgery
criteria: 
gender: Female
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lei Li, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Lei Li, MD
phone: 13911988831
phone ext: +86
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Professor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Colorectal Neoplasms
mesh term: Hereditary Breast and Ovarian Cancer Syndrome
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
sharing ipd: Undecided