Clinical trial NCT04289233: Molecular & Cellular Characterisation of Oral Lichen Planus
Official title: Molecular & Cellular Characterisation of Oral Lichen Planus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lichen Planus
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Histological architecture
timeFrame: Through study completion, (maximum 12 months from the defined end of study)
measure: Comparisons with other dysplastic lesions
timeFrame: Through study completion, (maximum 12 months from the defined end of study)
measure: Statistical classifications
timeFrame: Through study completion, (maximum 12 months from the defined end of study)
measure: Automation of morphological features
timeFrame: Through study completion, (maximum 12 months from the defined end of study)
measure: Molecular expression of Oral Lichen Planus markers
timeFrame: Through study completion, (maximum 12 months from the defined end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Dental Hospital and School of Dentistry
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Gabriel Landini, Phd
role: PRINCIPAL_INVESTIGATOR
References: