<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/NCT02220192</url>
  </required_header>
  <id_info>
    <org_study_id>F140613004 (UAB 1425)</org_study_id>
    <secondary_id>000344450-SP012</secondary_id>
    <nct_id>NCT02220192</nct_id>
  </id_info>
  <brief_title>An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure</brief_title>
  <official_title>Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to test the short-term effectiveness of an alternative treatment&#xD;
      approach for precancerous cells of the cervix. The study will also explore whether this new&#xD;
      treatment is feasible to perform and if it is acceptable to patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard treatment for precancerous cells of the cervix is called electrosurgical excision&#xD;
      procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved&#xD;
      equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the&#xD;
      visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual&#xD;
      symptoms will be monitored as well as the patient's thoughts and recommendations of the&#xD;
      procedure. The total amount of time of study participation is six months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Number of cases of recurrent high-grade cervical intraepithelial neoplasia</measure>
    <time_frame>6 months</time_frame>
    <description>Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of focal LEEP procedure</measure>
    <time_frame>2 weeks following focal LEEP procedure</time_frame>
    <description>A 15-minute questionnaire will be conducted by phone with the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia</measure>
    <time_frame>Within 1 week following focal LEEP procedure</time_frame>
    <description>A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>High-grade Cervical Intraepithelial Neoplasia</condition>
  <arm_group>
    <arm_group_label>Focal LEEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will undergo focal treatment of high-grade cervical intraepithelial neoplasia using LEEP. A two-week follow-up assessment will evaluate the side effects of the treatment and any unusual symptoms. This will be done through a phone survey. At six months a clinic visit is required to assess whether there are any precancerous cells of the patient's cervix.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Focal LEEP</intervention_name>
    <description>Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.</description>
    <arm_group_label>Focal LEEP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-45 years old&#xD;
&#xD;
          -  Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or&#xD;
             CIN2/3). A copy of the pathology report is required at the time of enrollment. We will&#xD;
             only include patients that had their biopsy performed at the UAB Colposcopy clinic&#xD;
             because those that return for treatment represent a select group that is more reliable&#xD;
             for follow-up given the standard no-show rate of 50% at the clinic.&#xD;
&#xD;
          -  Focal lesion visualized in its entirety colposcopically and involving less than or&#xD;
             equal to 2 quadrants of the cervix.&#xD;
&#xD;
          -  Satisfactory (adequate) colposcopy.&#xD;
&#xD;
          -  Lives within 100 miles of the University of Alabama at Birmingham.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any suspicion for invasive cancer.&#xD;
&#xD;
          -  Glandular abnormalities on cytology or histology.&#xD;
&#xD;
          -  Cervical lesion incompletely visualized (e.g. extending into the endocervical canal).&#xD;
&#xD;
          -  Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.&#xD;
&#xD;
          -  Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient&#xD;
             that lives &gt;100 miles away will be excluded due to concern for possible loss to&#xD;
             follow-up.&#xD;
&#xD;
          -  Immunosuppression (HIV positive, history of transplantation, lupus on&#xD;
             immunosuppressive medication, etc.).&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Mental condition rendering the subject unable to understand the nature, scope, and&#xD;
             possible consequences of the study.&#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>Michelle J Khan, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama of Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>April 5, 2016</last_update_submitted>
  <last_update_submitted_qc>April 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Michelle Khan</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cervical neoplasia</keyword>
  <keyword>cervix</keyword>
  <keyword>high-grade dysplasia</keyword>
  <keyword>LEEP (loop electrosurgical excision procedure)</keyword>
  <keyword>precancerous cells</keyword>
  <keyword>colposcopy</keyword>
  <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>
  <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/NCT02220192
org study id: F140613004 (UAB 1425)
secondary id: 000344450-SP012
nct id: NCT02220192
lead sponsor: 
collaborator: 
has dmc: Yes
This is a pilot study to test the short-term effectiveness of an alternative treatment
      approach for precancerous cells of the cervix. The study will also explore whether this new
      treatment is feasible to perform and if it is acceptable to patients.
Standard treatment for precancerous cells of the cervix is called electrosurgical excision
      procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved
      equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the
      visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual
      symptoms will be monitored as well as the patient's thoughts and recommendations of the
      procedure. The total amount of time of study participation is six months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cases of recurrent high-grade cervical intraepithelial neoplasia
time frame: 6 months
description: Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.
measure: Acceptability of focal LEEP procedure
time frame: 2 weeks following focal LEEP procedure
description: A 15-minute questionnaire will be conducted by phone with the patient.
measure: Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia
time frame: Within 1 week following focal LEEP procedure
description: A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.
arm group label: Focal LEEP
arm group type: Experimental
description: All patients will undergo focal treatment of high-grade cervical intraepithelial neoplasia using LEEP. A two-week follow-up assessment will evaluate the side effects of the treatment and any unusual symptoms. This will be done through a phone survey. At six months a clinic visit is required to assess whether there are any precancerous cells of the patient's cervix.
intervention type: Procedure
intervention name: Focal LEEP
description: Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.
arm group label: Focal LEEP
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: No
last name: Michelle J Khan, MD, MPH
role: Principal Investigator
affiliation: University of Alabama of Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Michelle Khan
investigator title: Assistant Professor
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Uterine Cervical Dysplasia
sharing ipd: No