<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/NCT01709773</url>
  </required_header>
  <id_info>
    <org_study_id>12503</org_study_id>
    <nct_id>NCT01709773</nct_id>
  </id_info>
  <brief_title>Focal Ablation of Cervical Precancer</brief_title>
  <official_title>Focal Ablation of High-grade Cervical Intraepithelial Neoplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot cohort study of women undergoing focal ablation for high-grade cervical&#xD;
      intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics.&#xD;
      The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting&#xD;
      inclusion criteria were recruited for enrollment into the pilot study of focal treatment.&#xD;
      Upon enrollment, they underwent focal ablational treatment rather than standard ablational&#xD;
      treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess&#xD;
      safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be&#xD;
      calculated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2013</start_date>
  <completion_date type="Actual">May 26, 2014</completion_date>
  <primary_completion_date type="Actual">April 11, 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Six-month recurrence rate of high-grade cervical intraepithelial neoplasia</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of focal treatment</measure>
    <time_frame>six months</time_frame>
    <description>Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of focal treatment</measure>
    <time_frame>six months</time_frame>
    <description>Participants will be asked to respond to a survey at enrollment and follow-up asking whether they are satisfied with focal treatment as an alternative method of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of focal treatment</measure>
    <time_frame>enrollment</time_frame>
    <description>Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>High-grade Cervical Intraepithelial Neoplasia</condition>
  <arm_group>
    <arm_group_label>Focal treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Focal treatment</intervention_name>
    <description>Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure</description>
    <arm_group_label>Focal treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-45 yo&#xD;
&#xD;
          -  Biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3&#xD;
&#xD;
          -  Satisfactory colposcopy, i.e., the entire transformation zone is visible&#xD;
&#xD;
          -  Lesion occupying &lt;= 2 quadrants of the cervix.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unsatisfactory colposcopy.&#xD;
&#xD;
          -  Colposcopic lesion extending into the endocervical canal beyond colposcopic&#xD;
             visualization.&#xD;
&#xD;
          -  Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.&#xD;
&#xD;
          -  Suspicion for invasive cancer on colposcopic exam.&#xD;
&#xD;
          -  Glandular dysplasia or atypical glandular cells on cytology.&#xD;
&#xD;
          -  Unreliable for follow-up.&#xD;
&#xD;
          -  Immunosuppression (HIV, transplant recipient, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Smith-McCune, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</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/NCT01709773
org study id: 12503
nct id: NCT01709773
lead sponsor: 
has dmc: No
This is a pilot cohort study of women undergoing focal ablation for high-grade cervical
      intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics.
      The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting
      inclusion criteria were recruited for enrollment into the pilot study of focal treatment.
      Upon enrollment, they underwent focal ablational treatment rather than standard ablational
      treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess
      safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be
      calculated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
time frame: six months
measure: Safety of focal treatment
time frame: six months
description: Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).
measure: Acceptability of focal treatment
time frame: six months
description: Participants will be asked to respond to a survey at enrollment and follow-up asking whether they are satisfied with focal treatment as an alternative method of treatment.
measure: Feasibility of focal treatment
time frame: enrollment
description: Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
arm group label: Focal treatment arm
arm group type: Experimental
intervention type: Procedure
intervention name: Focal treatment
description: Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
arm group label: Focal treatment arm
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: No
last name: Karen Smith-McCune, MD, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Uterine Cervical Dysplasia