<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/NCT03786601</url>
  </required_header>
  <id_info>
    <org_study_id>PMWVM</org_study_id>
    <nct_id>NCT03786601</nct_id>
  </id_info>
  <brief_title>Postmenopausal Women With Vaginal Microbiota</brief_title>
  <official_title>High-risk HPV Infection and Vaginal Microbiota in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</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>
      Since other genital infections enhance HIV susceptibility by inducing inflammation, the&#xD;
      investigators study the relationship between the vaginal microbiota composition and the risk&#xD;
      of HPV infection, cervical cytological abnormalities in postmenopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not&#xD;
      sufficient for the development of cervical cancer. Additional factors correlated with HPV&#xD;
      persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and,&#xD;
      more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked&#xD;
      reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of&#xD;
      anaerobic bacterial species. Owing to the decrease of estrogen level and cervical atrophy in&#xD;
      postmenopausal women, cervical cytology is more prone to abnormal changes than in&#xD;
      premenopausal women. Clinically, cervical lesions in elderly women are easily neglected.&#xD;
      Therefore, cervical cancer in the elderly is usually found in advanced stage, with poor&#xD;
      prognosis and more complications of treatment. Based on this, the investigators are going to&#xD;
      analyze the changes of microbiota in women with high-risk HPV and the cervical lesions in&#xD;
      menopausal women. And the investigators hope to figure out the difference and change in&#xD;
      microbiota to realize the tanning of cervical lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 25, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Vaginal microbiota and HR-HPV infection in menopausal women</measure>
    <time_frame>6 months</time_frame>
    <description>The persistence vaginal organism in HPV infection menopausal women</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference of vaginal microbiota in different age groups</measure>
    <time_frame>6 months</time_frame>
    <description>The difference of vaginal microbiota in different age groups with HR-HPV infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference of vaginal microbiota in different age groups</measure>
    <time_frame>6 months</time_frame>
    <description>The difference of vaginal microbiota in different age groups without HR-HPV</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">1</enrollment>
  <condition>HPV-Related Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Group A,</arm_group_label>
    <description>High-risk HPV infection in postmenopausal women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>High-risk HPV negative in postmenopausal women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>High-risk HPV infection in gestational women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <description>High-risk HPV negative in gestational women</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>The participants were assigned to different groups according to the results of HPV detection.</description>
    <arm_group_label>Group A,</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participants sample was referred to the paper already published.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those are aged 20 to 75 years old, have had vaginal intercourse more than 3 years, and&#xD;
             aren't in menstrual, pregnancy or puerperium period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those have no vaginal intercourse, and can't cooperate the examiner. Women who are HIV&#xD;
             or hepatitis B/C positive, have autoimmune disorders and systemic disease (like&#xD;
             diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction),&#xD;
             or have severe mental illness and malignant tumors are also excluded. At the same&#xD;
             time, all the participants should meet the following requirements: no vagina douching&#xD;
             within last 2 days, no vaginal intercourse within last 3 days, no systemic application&#xD;
             of antifungal agents or antibiotics or pessaries within last 14 days of sampling.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Shu Wang</last_name>
    <phone>+86-18810535568</phone>
    <email>chaoxp_pumch@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Xu</last_name>
      <phone>+86-010-69156874</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>shuwang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Squamous Cell</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/NCT03786601
org study id: PMWVM
nct id: NCT03786601
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Since other genital infections enhance HIV susceptibility by inducing inflammation, the
      investigators study the relationship between the vaginal microbiota composition and the risk
      of HPV infection, cervical cytological abnormalities in postmenopausal women.
Persistent infection with oncogenic Human Papillomavirus (HPV) is necessary but not
      sufficient for the development of cervical cancer. Additional factors correlated with HPV
      persistence include immunodeficiency caused by HIV, smoking, use of oral contraceptives and,
      more recently reported, vaginal dysbiosis. In a state of dysbiosis, there is a marked
      reduction of Lactobacillus and a high diversity of bacteria, with increased abundance of
      anaerobic bacterial species. Owing to the decrease of estrogen level and cervical atrophy in
      postmenopausal women, cervical cytology is more prone to abnormal changes than in
      premenopausal women. Clinically, cervical lesions in elderly women are easily neglected.
      Therefore, cervical cancer in the elderly is usually found in advanced stage, with poor
      prognosis and more complications of treatment. Based on this, the investigators are going to
      analyze the changes of microbiota in women with high-risk HPV and the cervical lesions in
      menopausal women. And the investigators hope to figure out the difference and change in
      microbiota to realize the tanning of cervical lesions.
observational model: Case-Control
time perspective: Prospective
measure: Vaginal microbiota and HR-HPV infection in menopausal women
time frame: 6 months
description: The persistence vaginal organism in HPV infection menopausal women
measure: The difference of vaginal microbiota in different age groups
time frame: 6 months
description: The difference of vaginal microbiota in different age groups with HR-HPV infection
measure: The difference of vaginal microbiota in different age groups
time frame: 6 months
description: The difference of vaginal microbiota in different age groups without HR-HPV
arm group label: Group A,
description: High-risk HPV infection in postmenopausal women
arm group label: Group B
description: High-risk HPV negative in postmenopausal women
arm group label: Group C
description: High-risk HPV infection in gestational women
arm group label: Group D
description: High-risk HPV negative in gestational women
intervention type: Other
intervention name: Observation
description: The participants were assigned to different groups according to the results of HPV detection.
arm group label: Group A,
arm group label: Group C
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 75 Years
last name: Shu Wang
phone: +86-18810535568
email: chaoxp_pumch@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: shuwang
investigator title: Associate Professor
mesh term: Carcinoma, Squamous Cell