Skip to content

Molecular & Cellular Characterisation of Oral Lichen Planus

Molecular & Cellular Characterisation of Oral Lichen Planus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04289233
Enrollment
70
Registered
2020-02-28
Start date
2016-10-26
Completion date
2023-02-26
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

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?

Interventions

None listed

Sponsors

University of Birmingham
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Histological architectureThrough 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?
Comparisons with other dysplastic lesionsThrough 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
Statistical classificationsThrough 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 featuresThrough study completion, (maximum 12 months from the defined end of study)Is it possible to automate such morphometrical analysis/classification?
Molecular expression of Oral Lichen Planus markersThrough 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?

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026