<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/NCT04472377</url>
  </required_header>
  <id_info>
    <org_study_id>HT19-HPV-01</org_study_id>
    <nct_id>NCT04472377</nct_id>
  </id_info>
  <brief_title>Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface</brief_title>
  <official_title>Evaluate the Agreement of High-risk Human Papillomavirus Type Between Self-collected Vaginal Discharge Sample Using &quot;HygeiaTouch Self Sampling Kit for Woman&quot; and Physician Collected Sample From the Cervix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hygeia Touch Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hygeia Touch Inc.</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>
      Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device &quot;Hygeia Touch&#xD;
      Self Sampling Kit for Women&quot; to self-collect the vaginal discharge sample for high-risk Human&#xD;
      Papillomavirus (hrHPV) detection.&#xD;
&#xD;
      This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal&#xD;
      self-sampling using &quot;Hygeia Touch Self Sampling Kit for Women&quot; and physician sampling, and&#xD;
      these results will be applied for TFDA registration approval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary end-point:&#xD;
&#xD;
        1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,&#xD;
           59, 66, and 68, between the physician-collected sample and self-collected sample&#xD;
&#xD;
        2. Agreement of the presence of hr-HPV between the physician-collected sample and&#xD;
           self-collected sample&#xD;
&#xD;
      Secondary end-point:&#xD;
&#xD;
        1. Percentage of the valid sample between self-collected and physician-collected specimens&#xD;
&#xD;
        2. Agreement of all (N = 27) HPV types between the paired samples&#xD;
&#xD;
        3. Adverse events associated with sample collection&#xD;
&#xD;
        4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal&#xD;
           discharge sample using &quot;Hygeia Touch Self Sampling Kit for Women&quot; through a short movie&#xD;
           and a brief illustration&#xD;
&#xD;
        5. Correlation between histological diagnosis and HPV types&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Actual">April 18, 2022</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Two samples were collected, one by the study investigator using a cervical swab and another one by the patient using the study device immediately after viewing the instruction video and illustration. The association of the self-collected sample and the physician-collected sample was blinded to the laboratory personnel.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>the specimen was marked by code which was intended to mask the sample pairing</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement in the detection of high-risk HPV type in physician collected specimen and patient sampled specimen.</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Rate of the &quot;agreement&quot;. The &quot;agreement&quot; is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Agreement in HPV detection between physician collected sample and self-collected sample</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Rate of the &quot;agreement&quot;. The &quot;agreement&quot; is defined as either (1) presence of any HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of any HPV in physician collected specimen and the patient sampled specimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of a valid specimen, according to the presence of the beta-globin gene in the self-collected specimen, and compares to the physician-collected specimen</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any adverse event resulted from collecting the specimen</measure>
    <time_frame>within one month after sample collection</time_frame>
    <description>The number of participants with any adverse event.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1210</enrollment>
  <condition>Human Papillomavirus Infection</condition>
  <condition>Self Sampling</condition>
  <condition>Vaginal Discharge</condition>
  <arm_group>
    <arm_group_label>study population</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We enroll a total of 1,200 women, as follows,&#xD;
120 cases with no history or current cervical intraepithelial lesion or malignancy.&#xD;
180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell.&#xD;
240 cases with a history of atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.&#xD;
240 cases with current ASCUS, CIN1, or atypical glandular cell.&#xD;
420 cases with current abnormal Pap test as atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Self sampling kit for collecting discharge from vaginal fornix</intervention_name>
    <description>A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.</description>
    <arm_group_label>study population</arm_group_label>
    <other_name>Hygeia Touch Self Sampling Kit for Women</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Woman with a uterine cervix, i.e., with no previous total hysterectomy or radiotherapy&#xD;
        for cervical tumor. The woman who received subtotal hysterectomy is allowed.&#xD;
&#xD;
        2. Signed informed consent. 3. Fit any one of the following conditions,&#xD;
&#xD;
          1. with no history or current cervical intraepithelial lesion or malignancy.&#xD;
&#xD;
          2. with a history of abnormal Pap test including atypical squamous cells of undetermined&#xD;
             significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell.&#xD;
&#xD;
          3. with a history of atypical squamous cells favor high-grade squamous intraepithelial&#xD;
             lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical&#xD;
             intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3,&#xD;
             cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor&#xD;
             neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.&#xD;
&#xD;
          4. with current atypical squamous cells of undetermined significance, cervical&#xD;
             intraepithelial neoplasia grade 1, or atypical glandular cell.&#xD;
&#xD;
          5. with current abnormal Pap test as atypical squamous cells favor high-grade squamous&#xD;
             intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial&#xD;
             lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia&#xD;
             grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells&#xD;
             favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of total hysterectomy&#xD;
&#xD;
          2. Pregnant&#xD;
&#xD;
          3. Current cervicitis that requires therapy&#xD;
&#xD;
          4. Received treatment for cervical lesion within 90 days&#xD;
&#xD;
          5. Had undergone radiotherapy or is receiving radiation over the uterus, cervix or vagina&#xD;
&#xD;
          6. Had sexual activity without a condom in 48 hours&#xD;
&#xD;
          7. Excessive vaginal discharge, either in the ovulation period or due to inflammation&#xD;
&#xD;
          8. is undergoing local therapy with an intravaginal tablet or residual drug in the&#xD;
             vaginal canal&#xD;
&#xD;
          9. during mense&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Detection of HPV in female genital tract.</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hung-Hsueh Chou, MBBS, VS</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833161</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>April 17, 2022</last_update_submitted>
  <last_update_submitted_qc>April 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical screening</keyword>
  <keyword>human papillomavirus typing</keyword>
  <keyword>self sampling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Vaginal Discharge</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>For clinical trial participation.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>3 months after accepting for report publication</ipd_time_frame>
    <ipd_access_criteria>to the public</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>July 21, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04472377
org study id: HT19-HPV-01
nct id: NCT04472377
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch
      Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human
      Papillomavirus (hrHPV) detection.

      This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal
      self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and
      these results will be applied for TFDA registration approval.
Primary end-point:

        1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
           59, 66, and 68, between the physician-collected sample and self-collected sample

        2. Agreement of the presence of hr-HPV between the physician-collected sample and
           self-collected sample

      Secondary end-point:

        1. Percentage of the valid sample between self-collected and physician-collected specimens

        2. Agreement of all (N = 27) HPV types between the paired samples

        3. Adverse events associated with sample collection

        4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal
           discharge sample using "Hygeia Touch Self Sampling Kit for Women" through a short movie
           and a brief illustration

        5. Correlation between histological diagnosis and HPV types
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Two samples were collected, one by the study investigator using a cervical swab and another one by the patient using the study device immediately after viewing the instruction video and illustration. The association of the self-collected sample and the physician-collected sample was blinded to the laboratory personnel.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: the specimen was marked by code which was intended to mask the sample pairing
measure: Agreement in the detection of high-risk HPV type in physician collected specimen and patient sampled specimen.
time frame: through study completion, an average of 1 year
description: Rate of the "agreement". The "agreement" is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen.
measure: Agreement in HPV detection between physician collected sample and self-collected sample
time frame: through study completion, an average of 1 year
description: Rate of the "agreement". The "agreement" is defined as either (1) presence of any HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of any HPV in physician collected specimen and the patient sampled specimen.
measure: Percentage of a valid specimen, according to the presence of the beta-globin gene in the self-collected specimen, and compares to the physician-collected specimen
time frame: through study completion, an average of 1 year
description: Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.
measure: Any adverse event resulted from collecting the specimen
time frame: within one month after sample collection
description: The number of participants with any adverse event.
arm group label: study population
arm group type: Experimental
description: We enroll a total of 1,200 women, as follows,
120 cases with no history or current cervical intraepithelial lesion or malignancy.
180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell.
240 cases with a history of atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.
240 cases with current ASCUS, CIN1, or atypical glandular cell.
420 cases with current abnormal Pap test as atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.
intervention type: Device
intervention name: Self sampling kit for collecting discharge from vaginal fornix
description: A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
arm group label: study population
other name: Hygeia Touch Self Sampling Kit for Women
criteria: 
gender: Female
gender based: Yes
gender description: Detection of HPV in female genital tract.
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hung-Hsueh Chou, MBBS, VS
role: Study Chair
affiliation: Chang Gung Memorial Hospital
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Papillomavirus Infections
mesh term: Vaginal Discharge
sharing ipd: Yes
ipd description: For clinical trial participation.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 3 months after accepting for report publication
ipd access criteria: to the public
submitted: July 21, 2023