Molecular & Cellular Characterisation of Oral Lichen Planus

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.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

• Study Contact: Name: Gabriel Landini, PhD; Phone Number: +44 0121 466 5519; Email: G.Landini@bham.ac.uk
• Study Contact Backup: Name: Ana Poveda Gallego, Consultant; Phone Number: +44 0121 466 6670; Email: p.g.ana@bham.ac.uk

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B5 7EG
      • Birmingham Dental Hospital and School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients registered at Birmingham Dental Hospital and attending a clinic for OLP diagnosis.

Patients will be identified by their normal healthcare consultant and invited to participate.

Informed consent will always be obtained prior to any study related procedures being undertaken.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Birmingham
• Investigators: Principal Investigator: Gabriel Landini, Phd, University of Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2016
• Primary Completion (Actual): February 26, 2023
• Study Completion (Actual): February 26, 2023

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: RG_15-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No