Molecular & Cellular Characterisation of Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:

Molecular & Cellular Characterisation of Oral Lichen Planus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289233
• Other study ID #: RG_15-112
• Status: Completed
• Start date: October 26, 2016
• Est. completion date: February 26, 2023

Study information

• Verified date: April 2021
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 26, 2023
• Est. primary completion date: February 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Locations

Country	Name	City	State
United Kingdom	Birmingham Dental Hospital and School of Dentistry	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological architecture	Are the histological architectural tissue changes that take place in oral lichen planus quantifiable using computer based imaging, graph theory and fractal geometry principles?	Through study completion, (maximum 12 months from the defined end of study)
Primary	Comparisons with other dysplastic lesions	What is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia	Through study completion, (maximum 12 months from the defined end of study)
Primary	Statistical classifications	Is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology	Through study completion, (maximum 12 months from the defined end of study)
Primary	Automation of morphological features	Is it possible to automate such morphometrical analysis/classification?	Through study completion, (maximum 12 months from the defined end of study)
Primary	Molecular expression of Oral Lichen Planus markers	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?	Through study completion, (maximum 12 months from the defined end of study)