<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/NCT02253719</url>
  </required_header>
  <id_info>
    <org_study_id>SHCH-Cervical Screening-VIA</org_study_id>
    <nct_id>NCT02253719</nct_id>
  </id_info>
  <brief_title>Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia</brief_title>
  <official_title>Screening for Prevention of Cervical Cancer in HIV-positive and HIV-negative Cambodian Women Using Direct Visualization With Acetic Acid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sihanouk Hospital Center of HOPE</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sihanouk Hospital Center of HOPE</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of cervical neoplasia in Cambodia is not known. There are no screening&#xD;
      programs in place. The investigators plan on introducing a screening program based on WHO&#xD;
      criteria and utilizing visualization with acetic acid. Patients who are positive will be&#xD;
      offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and&#xD;
      hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of&#xD;
      whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of cervical neoplasia in HIV positive women</measure>
    <time_frame>up to 12 months</time_frame>
    <description>500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of cervical neoplasia in HIV negative women</measure>
    <time_frame>up to 12 months</time_frame>
    <description>500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment of HIV positive women who screen as positive</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment of HIV negative women who screen as positive</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Cervical Neoplasia</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>HIV positive women</arm_group_label>
    <description>500 HIV women will be recruited from the hospital's current patient base as well as the community</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV negative women</arm_group_label>
    <description>500 HIV women will be recruited from the hospital's current patient base as well as the community</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cryotherapy, further biopsy, LEEP, surgery as indicated</intervention_name>
    <description>These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.</description>
    <arm_group_label>HIV negative women</arm_group_label>
    <arm_group_label>HIV positive women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The 1000 women will be recruited from the current patient base of Sihanouk hospital and the&#xD;
        surrounding community.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female, age 30-49, able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, gross cervical mass, prior cervical cancer, unable to give informed&#xD;
             consent, prior complete hysterectomy, allergic to acetic acid&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thay Sovanarra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sihanouk Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sihanouk Hospital, St. 134, Sangkat Vealvong, Khan 7 Makara</name>
      <address>
        <city>Phnom Pehn</city>
        <country>Cambodia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cambodia</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>October 6, 2015</last_update_submitted>
  <last_update_submitted_qc>October 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical neoplasia</keyword>
  <keyword>cervical cancer'</keyword>
  <keyword>visual inspection acetic acid</keyword>
  <keyword>cryotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Neoplasms</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/NCT02253719
org study id: SHCH-Cervical Screening-VIA
nct id: NCT02253719
lead sponsor: 
has dmc: Yes
The prevalence of cervical neoplasia in Cambodia is not known. There are no screening
      programs in place. The investigators plan on introducing a screening program based on WHO
      criteria and utilizing visualization with acetic acid. Patients who are positive will be
      offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and
      hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of
      whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).
observational model: Cohort
time perspective: Prospective
measure: Prevalence of cervical neoplasia in HIV positive women
time frame: up to 12 months
description: 500 HIV positive women will be screened for cervical neoplasia using direct visualization with acetic acid
measure: Prevalence of cervical neoplasia in HIV negative women
time frame: up to 12 months
description: 500 HIV negative women will be screened for cervical neoplasia using direct visualization with acetic acid
measure: Treatment of HIV positive women who screen as positive
time frame: up to 12 months
description: Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated.
measure: Treatment of HIV negative women who screen as positive
time frame: up to 12 months
description: Patients who screen positive will be offered same-day cryotherapy, further diagnostic work-up, and further therapeutic options such as LEEP and hysterectomy as clinically indicated.
arm group label: HIV positive women
description: 500 HIV women will be recruited from the hospital's current patient base as well as the community
arm group label: HIV negative women
description: 500 HIV women will be recruited from the hospital's current patient base as well as the community
intervention type: Procedure
intervention name: cryotherapy, further biopsy, LEEP, surgery as indicated
description: These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.
arm group label: HIV negative women
arm group label: HIV positive women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thay Sovanarra, MD
role: Principal Investigator
affiliation: Sihanouk Hospital
facility: 
country: Cambodia
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Neoplasms