Molecular & Cellular Characterisation of Oral Lichen Planus

Sponsor
University of Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04289233
Collaborator
(none)
150
1
76
2

Study Details

Study Description

Brief Summary

The principal research objective is to provide enhanced understanding of the cellular and molecular events important in the pathogenesis of Oral Lichen Planus to enable improved diagnosis and development of novel treatments for patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The following questions will also be addressed:
    1. Are the histological architectural tissue changes that take place in oral lichen planus quantifiable using computer based imaging, graph theory and fractal geometry principles? Quantification of these changes would allow the development of a tool to facilitate the accurate measurement of response to treatment.

    2. What is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia (the investigators have morphometrical data collected from previous research to allow such comparisons).

    3. Is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology? This would contribute towards making histopathological diagnosis more quantitative, reproducible and accurate.

    4. Is it possible to automate such morphometrical analysis/classification? This would allow large data sets to be screened automatically in a shorter time frame and at lower cost than human based screening.

    5. Is it possible to determine differences in genetics and gene expression of keratinocytes involved in Oral Lichen Planus compared to those of 'normal' tissue by using biopsy material and an in vitro model of oral lichen planus?

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Molecular & Cellular Characterisation of Oral Lichen Planus
    Actual Study Start Date :
    Oct 26, 2016
    Anticipated Primary Completion Date :
    Feb 26, 2023
    Anticipated Study Completion Date :
    Feb 26, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Histological architecture [Through study completion, (maximum 12 months from the defined end of study)]

      Are the histological architectural tissue changes that take place in oral lichen planus quantifiable using computer based imaging, graph theory and fractal geometry principles?

    2. Comparisons with other dysplastic lesions [Through study completion, (maximum 12 months from the defined end of study)]

      What is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia

    3. Statistical classifications [Through study completion, (maximum 12 months from the defined end of study)]

      Is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology

    4. Automation of morphological features [Through study completion, (maximum 12 months from the defined end of study)]

      Is it possible to automate such morphometrical analysis/classification?

    5. Molecular expression of Oral Lichen Planus markers [Through study completion, (maximum 12 months from the defined end of study)]

      Is it possible to determine differences in genetics and gene expression of keratinocytes involved in Oral Lichen Planus compared to those of 'normal' tissue by using biopsy material and an in vitro model of oral lichen planus?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patient is 16 years old or over

    2. Patient is willing and able to provide valid informed consent

    3. Patient is attending the Oral Lichen Planus clinic and will be having a routine clinical biopsy taken

    Exclusion Criteria:
    1. Patient under 16 years old

    2. Patient is immunocompromised

    3. Patients with comorbid disease state e.g. other inflammatory disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Dental Hospital and School of Dentistry Birmingham West Midlands United Kingdom B5 7EG

    Sponsors and Collaborators

    • University of Birmingham

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Birmingham
    ClinicalTrials.gov Identifier:
    NCT04289233
    Other Study ID Numbers:
    • RG_15-112
    First Posted:
    Feb 28, 2020
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 22, 2021