<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/NCT02198365</url>
  </required_header>
  <id_info>
    <org_study_id>TGOG-128</org_study_id>
    <nct_id>NCT02198365</nct_id>
  </id_info>
  <brief_title>Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia</brief_title>
  <official_title>Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of Cervical Neoplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cathay General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cathay General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesis is HPV integration could result in expression of oncogene&#xD;
      transcripts, and not only constitutive expression but also the level of expression will be&#xD;
      decisive for transformation and the maintenance of the malignant phenotype. Moreover, the&#xD;
      expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the&#xD;
      severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the investigators proposal, the investigators will examine at least 250 baseline&#xD;
      liquid-based cytology specimens from women with normal cytology, low-grade squamous&#xD;
      intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs),&#xD;
      microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV&#xD;
      blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6,&#xD;
      and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are&#xD;
      the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral&#xD;
      DNA tested by real-time PCR and FISH, along with level of expression in mRNA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">March 2009</completion_date>
  <primary_completion_date type="Actual">January 2009</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>level of mRNA expression</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The integrated HPV DNA</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Group 1: normal pap smear Group 2: cervical neoplasia</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      HPV DNA and mRNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will examine 250 baseline liquid-based cytology specimens from women with 100 low-grade&#xD;
        squamous intraepithelial lesions (LSILs), 100 high-grade squamous intraepithelial lesions&#xD;
        (HSILs), 10 microinvasions and 40 invasive cervical cancers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cervical neoplasia&#xD;
&#xD;
               -  HPV infection patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no HPV infection&#xD;
&#xD;
               -  no intra-epithelial neoplasia lesion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chih-Ming Ho</last_name>
    <role>Study Chair</role>
    <affiliation>Gynecologic Cancer Center, Cathay General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cathay General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10630</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>January 4, 2009</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cathay General Hospital</investigator_affiliation>
    <investigator_full_name>Chih-Ming Ho</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>mRNA,</keyword>
  <keyword>DNA,</keyword>
  <keyword>integrated HPV DNA</keyword>
  <keyword>human papillomavirus,</keyword>
  <keyword>cervical neoplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</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/NCT02198365
org study id: TGOG-128
nct id: NCT02198365
lead sponsor: 
collaborator: 
has dmc: No
The investigators hypothesis is HPV integration could result in expression of oncogene
      transcripts, and not only constitutive expression but also the level of expression will be
      decisive for transformation and the maintenance of the malignant phenotype. Moreover, the
      expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the
      severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).
In the investigators proposal, the investigators will examine at least 250 baseline
      liquid-based cytology specimens from women with normal cytology, low-grade squamous
      intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs),
      microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV
      blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6,
      and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are
      the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral
      DNA tested by real-time PCR and FISH, along with level of expression in mRNA.
observational model: Case-Control
time perspective: Prospective
measure: level of mRNA expression
time frame: 12 month
measure: The integrated HPV DNA
time frame: 12 months
arm group label: Group 2
description: Group 1: normal pap smear Group 2: cervical neoplasia
HPV DNA and mRNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chih-Ming Ho
role: Study Chair
affiliation: Gynecologic Cancer Center, Cathay General Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Cathay General Hospital
investigator full name: Chih-Ming Ho
investigator title: Attending physician
mesh term: Neoplasms
mesh term: Uterine Cervical Dysplasia