xml: <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/NCT05997160</url>
    </required_header>
    <id_info>
      <org_study_id>IRB2023-YX-022-01</org_study_id>
      <nct_id>NCT05997160</nct_id>
    </id_info>
    <brief_title>Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining</brief_title>
    <acronym>VENUS</acronym>
    <official_title>Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jiangsu Bioperfectus Technologies Co., Ltd</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tianjin Medical University General 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>
        The goal of this observational study is to explore a standardized sample process for&#xD;
        improving the accuracy of vaginal microbiota evaluation and to explore a more complete and&#xD;
        comprehensive method for vaginal microbiota evaluation based on gram staining.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study consists of two sub-studies:&#xD;
  &#xD;
          1. Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims&#xD;
             to compare different slide preparation methods and dilution levels based on various&#xD;
             aspects, including uniformity, impurities, clarity and so on, and then explore the&#xD;
             optimal method and dilution level. Additionally, it will summarize the conversion method&#xD;
             for white blood cells between wet mount and gram staining, and for white blood cells&#xD;
             between high-power microscopy and oil immersion microscopy.&#xD;
  &#xD;
          2. Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed&#xD;
             vaginal infection type, it will calculate the consistency of results between different&#xD;
             laboratories. And it will evaluate the effectiveness combined artificial intelligence&#xD;
             technology and other technological platforms. Besides, for patients without diagnosed&#xD;
             vaginal infection type, different methods such as 16S rRNA gene sequencing and&#xD;
             metagenomic sequencing are used for analysis and profiling to guide treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The score for smear</measure>
      <time_frame>December 2023</time_frame>
      <description>This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnosis of vaginitis type</measure>
      <time_frame>March 2024</time_frame>
      <description>The Diagnosis of vaginitis type based on Gram-stained smear and antigen testing, including aerobic vaginitis(AV), bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), and normal.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Relative Abundance</measure>
      <time_frame>May 2024</time_frame>
      <description>Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intensity</measure>
      <time_frame>May 2024</time_frame>
      <description>The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">5590</enrollment>
    <condition>Vaginal Infection</condition>
    <arm_group>
      <arm_group_label>hospital name + infection type + number</arm_group_label>
      <description>There is no intervention.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          VENUS study plans to enrol 5590 participants, aged 15-49 years, from visiting our research&#xD;
          settings across the country who evaluate vaginal discharge based on Gram-stained smear.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Non-pregnant women who visit our research settings and conduct vaginal discharge&#xD;
               examination based on Gram-stained smear.&#xD;
  &#xD;
            -  No sexual intercourse, vaginal douching, or vaginal medication within the last 72&#xD;
               hours.&#xD;
  &#xD;
            -  Not during menstruation (menstrual period ended ≥3 days ago).&#xD;
  &#xD;
          exclusion Criteria:&#xD;
  &#xD;
            -  Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fengxia Xue, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin Medical University General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fengxia Xue, PhD</last_name>
      <phone>8615022655806</phone>
      <email>qiwenhui1987@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tianjin Medical University General Hospital</investigator_affiliation>
      <investigator_full_name>Fengxia Xue</investigator_full_name>
      <investigator_title>Director of the Medical Center for Obstetrics and Gynecology</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997160
  org study id: IRB2023-YX-022-01
  nct id: NCT05997160
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to explore a standardized sample process for
        improving the accuracy of vaginal microbiota evaluation and to explore a more complete and
        comprehensive method for vaginal microbiota evaluation based on gram staining.
  This study consists of two sub-studies:
  
          1. Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims
             to compare different slide preparation methods and dilution levels based on various
             aspects, including uniformity, impurities, clarity and so on, and then explore the
             optimal method and dilution level. Additionally, it will summarize the conversion method
             for white blood cells between wet mount and gram staining, and for white blood cells
             between high-power microscopy and oil immersion microscopy.
  
          2. Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed
             vaginal infection type, it will calculate the consistency of results between different
             laboratories. And it will evaluate the effectiveness combined artificial intelligence
             technology and other technological platforms. Besides, for patients without diagnosed
             vaginal infection type, different methods such as 16S rRNA gene sequencing and
             metagenomic sequencing are used for analysis and profiling to guide treatment.
  observational model: Other
  time perspective: Cross-Sectional
  measure: The score for smear
  time frame: December 2023
  description: This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear.
  measure: Diagnosis of vaginitis type
  time frame: March 2024
  description: The Diagnosis of vaginitis type based on Gram-stained smear and antigen testing, including aerobic vaginitis(AV), bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), and normal.
  measure: Relative Abundance
  time frame: May 2024
  description: Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis.
  measure: Intensity
  time frame: May 2024
  description: The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis.
  arm group label: hospital name + infection type + number
  description: There is no intervention.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 15 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fengxia Xue, PhD
  role: Principal Investigator
  affiliation: Tianjin Medical University General Hospital
  last name: Fengxia Xue, PhD
  phone: 8615022655806
  email: qiwenhui1987@163.com
  responsible party type: Principal Investigator
  investigator affiliation: Tianjin Medical University General Hospital
  investigator full name: Fengxia Xue
  investigator title: Director of the Medical Center for Obstetrics and Gynecology