<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/NCT03024866</url>
  </required_header>
  <id_info>
    <org_study_id>CTPR-0014</org_study_id>
    <nct_id>NCT03024866</nct_id>
  </id_info>
  <brief_title>Electronic Brachytherapy (eBx)-Mohs Matched Pair - Cohort Study A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery</brief_title>
  <official_title>Electronic Brachytherapy (eBx)-Mohs Matched Pair - Cohort Study A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xoft, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eminence Clinical Research, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Xoft, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective-prospective study design. Patients who completed treatment&#xD;
      approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be&#xD;
      identified and any existing data in the patient's record will be collected in addition to&#xD;
      conducting office visits for long-term follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective-prospective study design. Patients who completed treatment&#xD;
      approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be&#xD;
      identified and any existing data in the patient's record will be collected in addition to&#xD;
      conducting office visits for long-term follow-up. The study will include 2 parts:&#xD;
&#xD;
        1. Retrospective chart review: Collect data from patient records who completed treatment a&#xD;
           minimum of 2 years prior to study onset and determine the feasibility of doing a matched&#xD;
           pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and&#xD;
           treatment data will be retrospectively collected from up to 320 subjects previously&#xD;
           treated with eBx for the treatment of NMSC and up to 320 subjects previously treated&#xD;
           with Mohs surgery for the treatment of NMSC.&#xD;
&#xD;
        2. Prospective Follow-up: Patients will return for long-term follow-up visits for the&#xD;
           investigators to assess the lesion site, document absence of recurrence/ absence of&#xD;
           recurrence, toxicities, and collect patient reported outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>Absence of local recurrence at approximately 3 to 5-year follow-up (range is approximately two to five years) at treatment site(s).</measure>
    <time_frame>Two to five years post treatment</time_frame>
    <description>Assessment of treatment site 2-5 years following treatment to determine if recurrence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of long-term toxicities related to eBx vs. Mohs treatment Using A Chronic Toxicity Questionnaire Based om Physician Assessment at Time of Visit</measure>
    <time_frame>Two to five years post treatment</time_frame>
    <description>Assessment of treatment site 2-5 years following treatment to determine if long-term toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of long-term cosmetic outcomes for lesions treated for NMSC with eBx vs. Mohs;</measure>
    <time_frame>Two to five years post treatment</time_frame>
    <description>Physician assessment of cosmetic outcome two to five years post treatment, at time of clinic visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic toxicities</measure>
    <time_frame>Two to five years post treatment</time_frame>
    <description>Physician assessment of treatment site to assess for chronic toxicites two to five years post treatment, at time of clinic visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Survey for reporting Patient Reported Outcomes (PRO)</measure>
    <time_frame>Two to five years post treatment</time_frame>
    <description>Patient completes a survey at a clinic visit two to five years post treatment at time of clinic visit</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Nonmelanoma Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Electronic Brachytherapy</arm_group_label>
    <description>Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mohs Surgery</arm_group_label>
    <description>Previously completed treatment for non-melanoma skin cancer using Mohs Surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 320 subjects treated with eBx and up to 320 subjects treated with Mohs surgery will&#xD;
        have data collected retrospectively from the patient's medical records, and prospectively&#xD;
        at the time of the follow-up visit for those who agree to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic&#xD;
             Brachytherapy System or Mohs surgery;&#xD;
&#xD;
          2. Provides informed Consent;&#xD;
&#xD;
          3. Greater than 40 years of age;&#xD;
&#xD;
          4. Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to&#xD;
             treatment;&#xD;
&#xD;
          5. Cancer Staging included in this study:&#xD;
&#xD;
               -  Stage 0: Tis, N0, M0&#xD;
&#xD;
               -  Stage 1: T1, N0, M0&#xD;
&#xD;
               -  Stage 2: T2, N0, M0 and ≤ 4cm in diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Target area is adjacent to a burn scar&#xD;
&#xD;
          2. Any prior definitive surgical resection of the cancer, prior to Radiation Treatment&#xD;
&#xD;
          3. Known perineural invasion&#xD;
&#xD;
          4. Actinic Keratosis&#xD;
&#xD;
          5. Known spread to regional lymph nodes&#xD;
&#xD;
          6. Known metastatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakesh Patel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Good Samaritan Radiation Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Strimling</last_name>
    <role>Principal Investigator</role>
    <affiliation>Strimling Dermatology, Laser, and Vein Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>John DeLucia</last_name>
    <phone>603-546-7430</phone>
    <email>jdelucia@icadmed.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joyce Musacchio</last_name>
    <phone>603-882-5200</phone>
    <phone_ext>7308</phone_ext>
    <email>jmusacchio@icadmed.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kenneth A. Miller, PC</name>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dermatology &amp; Laser Center of San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Willoughby, MD</last_name>
      <phone>619-754-8469</phone>
      <email>willoughby_mark@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dermatology and Laser Center of San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Willoughby, MD</last_name>
      <phone>619-320-4807</phone>
      <email>willoughby_mark@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Strimling Laser and Vein Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamie Butler</last_name>
      <phone>702-243-6400</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 15, 2017</last_update_submitted>
  <last_update_submitted_qc>January 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</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>Skin Neoplasms</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 20, 2018</submitted>
    <submission_canceled>July 2, 2018</submission_canceled>
    <submitted>July 2, 2018</submitted>
    <submission_canceled>July 3, 2018</submission_canceled>
    <submitted>July 3, 2018</submitted>
    <returned>January 11, 2019</returned>
    <submitted>February 16, 2022</submitted>
    <returned>April 18, 2022</returned>
    <submitted>December 9, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03024866
org study id: CTPR-0014
nct id: NCT03024866
lead sponsor: 
collaborator: 
has dmc: No
This is a retrospective-prospective study design. Patients who completed treatment
      approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be
      identified and any existing data in the patient's record will be collected in addition to
      conducting office visits for long-term follow-up.
This is a retrospective-prospective study design. Patients who completed treatment
      approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be
      identified and any existing data in the patient's record will be collected in addition to
      conducting office visits for long-term follow-up. The study will include 2 parts:

        1. Retrospective chart review: Collect data from patient records who completed treatment a
           minimum of 2 years prior to study onset and determine the feasibility of doing a matched
           pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and
           treatment data will be retrospectively collected from up to 320 subjects previously
           treated with eBx for the treatment of NMSC and up to 320 subjects previously treated
           with Mohs surgery for the treatment of NMSC.

        2. Prospective Follow-up: Patients will return for long-term follow-up visits for the
           investigators to assess the lesion site, document absence of recurrence/ absence of
           recurrence, toxicities, and collect patient reported outcomes.
observational model: Cohort
time perspective: Prospective
measure: Absence of local recurrence at approximately 3 to 5-year follow-up (range is approximately two to five years) at treatment site(s).
time frame: Two to five years post treatment
description: Assessment of treatment site 2-5 years following treatment to determine if recurrence
measure: Comparison of long-term toxicities related to eBx vs. Mohs treatment Using A Chronic Toxicity Questionnaire Based om Physician Assessment at Time of Visit
time frame: Two to five years post treatment
description: Assessment of treatment site 2-5 years following treatment to determine if long-term toxicity
measure: Comparison of long-term cosmetic outcomes for lesions treated for NMSC with eBx vs. Mohs;
time frame: Two to five years post treatment
description: Physician assessment of cosmetic outcome two to five years post treatment, at time of clinic visit.
measure: Chronic toxicities
time frame: Two to five years post treatment
description: Physician assessment of treatment site to assess for chronic toxicites two to five years post treatment, at time of clinic visit.
measure: Patient Survey for reporting Patient Reported Outcomes (PRO)
time frame: Two to five years post treatment
description: Patient completes a survey at a clinic visit two to five years post treatment at time of clinic visit
arm group label: Electronic Brachytherapy
description: Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
arm group label: Mohs Surgery
description: Previously completed treatment for non-melanoma skin cancer using Mohs Surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 41 Years
maximum age: N/A
healthy volunteers: No
last name: Rakesh Patel, MD
role: Principal Investigator
affiliation: Good Samaritan Radiation Oncology
last name: Robert Strimling
role: Principal Investigator
affiliation: Strimling Dermatology, Laser, and Vein Institute
last name: John DeLucia
phone: 603-546-7430
email: jdelucia@icadmed.com
last name: Joyce Musacchio
phone: 603-882-5200
phone ext: 7308
email: jmusacchio@icadmed.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Skin Neoplasms
submitted: March 20, 2018
submission canceled: July 2, 2018
submitted: July 2, 2018
submission canceled: July 3, 2018
submitted: July 3, 2018
returned: January 11, 2019
submitted: February 16, 2022
returned: April 18, 2022
submitted: December 9, 2022