Molecular & Cellular Characterisation of Oral Lichen Planus

NCT ID: NCT04289233

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-26

Study Completion Date

2023-02-26

Brief Summary

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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.

Detailed Description

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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?

Conditions

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Oral Lichen Planus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Landini, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

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Birmingham Dental Hospital and School of Dentistry

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RG_15-112

Identifier Type: -

Identifier Source: org_study_id

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