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CompletedNCT04289233Updated Apr 18, 2024

Molecular & Cellular Characterisation of Oral Lichen Planus

An observational study in Oral Lichen Planus, sponsored by University of Birmingham. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by University of Birmingham · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
70
Ages
16 Years and older
Sex
All
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Study 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.

Read the 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?
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Conditions studied

  • Oral Lichen Planus

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03

In context

Lichen Planus, Oral

143 studies on the registry are indexed under Lichen Planus, Oral; 25 are open to participants now.

This study's enrollment of 70 is close to the median of 75 across 38 observational studies indexed under Lichen Planus, Oral.

Browse Lichen Planus, Oral studies →

Lead sponsor

University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Patient under 16 years old
  2. Patient is immunocompromised
  3. Patients with comorbid disease state e.g. other inflammatory disease
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
70 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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?

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

  2. Comparisons with other dysplastic lesions

    What is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

  3. Statistical classifications

    Is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

  4. Automation of morphological features

    Is it possible to automate such morphometrical analysis/classification?

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

  5. 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?

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

07

Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04289233
Responsible party
Sponsor
First posted
Feb 28, 2020
Start date
Oct 26, 2016
Primary completion
Feb 26, 2023
Completion
Feb 26, 2023
Last update
Apr 18, 2024

Study contacts

Gabriel Landini, Phd
principal investigator · University of Birmingham

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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