Methods Validation Assessment for Study of Inflammatory Skin Disease

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03796806
Collaborator
(none)
1
1

Study Details

Study Description

Brief Summary

  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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Methods Validation Assessment for Study of Inflammatory Skin Disease
    Actual Study Start Date :
    Jan 14, 2019
    Actual Primary Completion Date :
    Jan 14, 2019
    Actual Study Completion Date :
    Jan 14, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue. [8 months]

      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.

    2. Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model [8 months]

      Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.

    3. Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model [8 months]

      Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults >18 years with active cutaneous lichen planus with capacity to consent.
    Exclusion Criteria:
    • Concurrent skin infection

    • Wound healing disturbances

    • Patients on systemic immunosuppressive medications.

    • Lidocaine allergy

    • Platelets <10,000

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Julia S Lehman, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Julia S. Lehman, Professor of Dermatology and Laboratory Medicine and Pathology, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03796806
    Other Study ID Numbers:
    • 18-002404
    First Posted:
    Jan 8, 2019
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Julia S. Lehman, Professor of Dermatology and Laboratory Medicine and Pathology, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021