Molecular & Cellular Characterisation of Oral Lichen Planus

Completed

• Conditions: Oral Lichen Planus

• Registration Number: NCT04289233
• Lead Sponsor: University of Birmingham

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.

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 Timeline

• Study Start: 2016-10-26
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2021-04
• Primary Completion: 2023-02-26
• Study Completion: 2023-02-26
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?
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?
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
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?
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

Trial Locations

Locations (1)

Birmingham Dental Hospital and School of Dentistry; 🇬🇧 Birmingham, West Midlands, United Kingdom