<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/NCT04415840</url>
  </required_header>
  <id_info>
    <org_study_id>COLPO-4</org_study_id>
    <nct_id>NCT04415840</nct_id>
  </id_info>
  <brief_title>Lugol's Solution in Addition to Acetic Acid During Colposcopy</brief_title>
  <official_title>Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zydolab - Institute of Cytology and Immune Cytochemistry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zydolab - Institute of Cytology and Immune Cytochemistry</source>
  <oversight_info>
    <has_dmc>No</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>
      To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy&#xD;
      in women with cervical dysplasia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 25, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution</measure>
    <time_frame>1 minute</time_frame>
    <description>We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>1 minute</time_frame>
    <description>sensitivity of the examination (acetic acid + Lugol´s solution)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity</measure>
    <time_frame>1 minute</time_frame>
    <description>Specificity of the examination (acetic acid + Lugol´s solution)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PPV</measure>
    <time_frame>1 minute</time_frame>
    <description>Positive predictive value of the examination (acetic acid + Lugol´s solution)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NPV</measure>
    <time_frame>1 minute</time_frame>
    <description>Negative predictive value of the examination (acetic acid + Lugol´s solution)</description>
  </secondary_outcome>
  <enrollment type="Actual">323</enrollment>
  <condition>Uterine Cervical Dysplasia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>acetic acid test</intervention_name>
    <description>using acetic acid to unmask dysplastic lesions on the cervix uteri</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lugol's solution test</intervention_name>
    <description>using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Non-pregnant women referred for colposcopy due to cervical abnormalities&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women referred for colposcopy due to cervical abnormalities&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  presence of a language barrier&#xD;
&#xD;
          -  history of conization or other treatments on the cervix uteri&#xD;
&#xD;
          -  iodine allergy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ziad Hilal, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zydolab - Institute of Cytology and Immune Cytochemistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zydolab - Institute of Cytology and Immune Cytochemistry</name>
      <address>
        <city>Dortmund</city>
        <state>NRW</state>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology of the Ruhr University Bochum</name>
      <address>
        <city>Herne</city>
        <state>NRW</state>
        <zip>44265</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 17, 2022</last_update_submitted>
  <last_update_submitted_qc>July 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical dysplasia</keyword>
  <keyword>colposcopy</keyword>
  <keyword>Lugol's solution</keyword>
  <keyword>acetic acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetic Acid</mesh_term>
    <mesh_term>Retinol acetate</mesh_term>
    <mesh_term>Lugol's solution</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04415840
org study id: COLPO-4
nct id: NCT04415840
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy
      in women with cervical dysplasia.
observational model: Other
time perspective: Prospective
measure: additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution
time frame: 1 minute
description: We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use
measure: Sensitivity
time frame: 1 minute
description: sensitivity of the examination (acetic acid + Lugol´s solution)
measure: Specificity
time frame: 1 minute
description: Specificity of the examination (acetic acid + Lugol´s solution)
measure: PPV
time frame: 1 minute
description: Positive predictive value of the examination (acetic acid + Lugol´s solution)
measure: NPV
time frame: 1 minute
description: Negative predictive value of the examination (acetic acid + Lugol´s solution)
intervention type: Diagnostic Test
intervention name: acetic acid test
description: using acetic acid to unmask dysplastic lesions on the cervix uteri
intervention type: Diagnostic Test
intervention name: Lugol's solution test
description: using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
last name: Ziad Hilal, M.D.
role: Principal Investigator
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Uterine Cervical Dysplasia
mesh term: Acetic Acid
mesh term: Retinol acetate
mesh term: Lugol's solution
sharing ipd: No