<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/NCT02250716</url>
  </required_header>
  <id_info>
    <org_study_id>CIN1</org_study_id>
    <nct_id>NCT02250716</nct_id>
  </id_info>
  <brief_title>A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women</brief_title>
  <official_title>A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Witwatersrand, South Africa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Witwatersrand, South Africa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on the high incidence of cervical cancer and high grade dysplasia and increased&#xD;
      progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the&#xD;
      effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month&#xD;
      cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for&#xD;
      HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen&#xD;
      Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have&#xD;
      had a colposcopic biopsy for persistent LSIL as per standard of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women with HIV have a higher risk of cervical cancer. Screening and treatment formaly of the&#xD;
      disease is limited die to poor access of screening programs and multiple visits. Women with&#xD;
      HIV also have high progressions rates of disease amd my need to be treated earliers.&#xD;
      Cryotherapy is a low option and very easy to implement especially in low resource provinces.&#xD;
&#xD;
        -  It is cheaper and easier to administer than Large Loop electrosurgical excision&#xD;
           procedure (LLETZ)&#xD;
&#xD;
        -  No histology or transportation costs of specimens&#xD;
&#xD;
        -  Less invasive than LLETZ&#xD;
&#xD;
        -  It is nurse driven and easily learned&#xD;
&#xD;
        -  It decreases loss to follow-up of patients due to reduced waiting time, transportation&#xD;
           costs, time off work and HIV stigma&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regresson of CIN1 to a normal biopsy</measure>
    <time_frame>12 month</time_frame>
    <description>Treatment failure is the progression of CIN1 to CIN2</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Cervical Dysplasia</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>12 month cytology and histology follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cryotherapy</intervention_name>
    <description>cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV -infected women whose biopsy proves CIN1 and who consent to study participants and&#xD;
             procedures&#xD;
&#xD;
          -  CIN1 with no visible lesion&#xD;
&#xD;
          -  The entire ectocervical lesion should cover less than 75% of the cervix and not more&#xD;
             than 2 - 3mm into the endocervical canal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Known and previous treatment for HSIL by any method (Cryotherapy, LEEP or cone biopsy)&#xD;
&#xD;
          -  Women who are menstruating or who have active pelvic inflammatory disease will be&#xD;
             deferred from the study until the infection is cleared or the menstrual cycle has&#xD;
             ended; the patient may then participate in the study.&#xD;
&#xD;
          -  Unsatisfactory colposcopic examination defined as inability to see the extent of the&#xD;
             lesion in the endocervical canal and lesions deemed ineligible for cryotherapy by an&#xD;
             OB/GYN specialist.&#xD;
&#xD;
          -  Previous hysterectomy with removal of the cervix&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia S Firnhaber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Witwatersrand, South Africa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Witwatersrand/Helen Joseph Hospital</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>December 1, 2015</last_update_submitted>
  <last_update_submitted_qc>December 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Witwatersrand, South Africa</investigator_affiliation>
    <investigator_full_name>Cynthia S Firnhaber</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>CIN1</keyword>
  <keyword>HIV seropositive women</keyword>
  <keyword>Cryotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</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/NCT02250716
org study id: CIN1
nct id: NCT02250716
lead sponsor: 
has dmc: No
Based on the high incidence of cervical cancer and high grade dysplasia and increased
      progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the
      effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month
      cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for
      HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen
      Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have
      had a colposcopic biopsy for persistent LSIL as per standard of care.
Women with HIV have a higher risk of cervical cancer. Screening and treatment formaly of the
      disease is limited die to poor access of screening programs and multiple visits. Women with
      HIV also have high progressions rates of disease amd my need to be treated earliers.
      Cryotherapy is a low option and very easy to implement especially in low resource provinces.

        -  It is cheaper and easier to administer than Large Loop electrosurgical excision
           procedure (LLETZ)

        -  No histology or transportation costs of specimens

        -  Less invasive than LLETZ

        -  It is nurse driven and easily learned

        -  It decreases loss to follow-up of patients due to reduced waiting time, transportation
           costs, time off work and HIV stigma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Regresson of CIN1 to a normal biopsy
time frame: 12 month
description: Treatment failure is the progression of CIN1 to CIN2
arm group label: Arm 1
arm group type: Experimental
description: Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up
arm group label: Arm 2
arm group type: No Intervention
description: 12 month cytology and histology follow-up
intervention type: Procedure
intervention name: cryotherapy
description: cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)
arm group label: Arm 1
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Cynthia S Firnhaber, MD
role: Principal Investigator
affiliation: University of Witwatersrand, South Africa
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of Witwatersrand, South Africa
investigator full name: Cynthia S Firnhaber
investigator title: Associate Professor of Medicine
mesh term: HIV Seropositivity
mesh term: Uterine Cervical Dysplasia