<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/NCT03796806</url>
  </required_header>
  <id_info>
    <org_study_id>18-002404</org_study_id>
    <nct_id>NCT03796806</nct_id>
  </id_info>
  <brief_title>Methods Validation Assessment for Study of Inflammatory Skin Disease</brief_title>
  <official_title>Methods Validation Assessment for Study of Inflammatory Skin Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Assess validity of methods involved in molecular studies of the skin in inflammatory&#xD;
           skin disease&#xD;
&#xD;
        2. Assess feasibility of methods for grafting fresh human skin (normal and diseased with&#xD;
           inflammatory skin disease) onto an established xenograft murine model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of fixed tissue specimens for research studies is attractive, because a large number&#xD;
      of relevant specimens can be collected quickly from tissue registry. There is a current lack&#xD;
      of knowledge regarding to what extent formalin fixation alters the identification of proteins&#xD;
      in the skin with inflammatory dermatoses. This information would be important to assess when&#xD;
      determining the limitations (or potentially lack thereof) of using fixed specimens in&#xD;
      research.&#xD;
&#xD;
      Collaborators have successfully developed a murine model that can accept human skin&#xD;
      xenografts. While those investigators have successfully demonstrated transplantation of&#xD;
      healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be&#xD;
      transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to&#xD;
      involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed&#xD;
      human skin using this model, as well as observing the course of this inflammation, are the&#xD;
      next steps in advancing this potentially invaluable research modality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">January 14, 2019</completion_date>
  <primary_completion_date type="Actual">January 14, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.</measure>
    <time_frame>8 months</time_frame>
    <description>Identification and quantification of proteins as obtained by liquid chromatography-mass spectrometry methods using fresh and formalin-fixed-paraffin-embedded tissue. Mass spectrometry data will be matched against a composite protein sequence database using the MyriMatch search engine and IDPicker will filter protein identification at 2% false discovery rate. QuasiTel software will process the spectral count data for the identification of differentially expressed proteins.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model</measure>
    <time_frame>8 months</time_frame>
    <description>Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model</measure>
    <time_frame>8 months</time_frame>
    <description>Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.</description>
  </primary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Lichen Planus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Clinic patients with active lichen planus and residing within a 50-mile radius of Mayo&#xD;
        Clinic-Rochester.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Adults &gt;18 years with active cutaneous lichen planus with capacity to consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent skin infection&#xD;
&#xD;
          -  Wound healing disturbances&#xD;
&#xD;
          -  Patients on systemic immunosuppressive medications.&#xD;
&#xD;
          -  Lidocaine allergy&#xD;
&#xD;
          -  Platelets &lt;10,000&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia S Lehman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Julia S. Lehman</investigator_full_name>
    <investigator_title>Professor of Dermatology and Laboratory Medicine and Pathology</investigator_title>
  </responsible_party>
  <keyword>lichen planus</keyword>
  <keyword>proteomics</keyword>
  <keyword>xenograft model for lichen planus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Diseases</mesh_term>
    <mesh_term>Lichen Planus</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/NCT03796806
org study id: 18-002404
nct id: NCT03796806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. Assess validity of methods involved in molecular studies of the skin in inflammatory
           skin disease

        2. Assess feasibility of methods for grafting fresh human skin (normal and diseased with
           inflammatory skin disease) onto an established xenograft murine model.
The use of fixed tissue specimens for research studies is attractive, because a large number
      of relevant specimens can be collected quickly from tissue registry. There is a current lack
      of knowledge regarding to what extent formalin fixation alters the identification of proteins
      in the skin with inflammatory dermatoses. This information would be important to assess when
      determining the limitations (or potentially lack thereof) of using fixed specimens in
      research.

      Collaborators have successfully developed a murine model that can accept human skin
      xenografts. While those investigators have successfully demonstrated transplantation of
      healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be
      transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to
      involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed
      human skin using this model, as well as observing the course of this inflammation, are the
      next steps in advancing this potentially invaluable research modality.
observational model: Case-Only
time perspective: Prospective
measure: Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.
time frame: 8 months
description: Identification and quantification of proteins as obtained by liquid chromatography-mass spectrometry methods using fresh and formalin-fixed-paraffin-embedded tissue. Mass spectrometry data will be matched against a composite protein sequence database using the MyriMatch search engine and IDPicker will filter protein identification at 2% false discovery rate. QuasiTel software will process the spectral count data for the identification of differentially expressed proteins.
measure: Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model
time frame: 8 months
description: Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.
measure: Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model
time frame: 8 months
description: Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julia S Lehman
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Julia S. Lehman
investigator title: Professor of Dermatology and Laboratory Medicine and Pathology
mesh term: Skin Diseases
mesh term: Lichen Planus