Oral Lichen PlanusNCT04289233
Molecular & Cellular Characterisation of Oral Lichen Planus
An observational study of Oral Lichen Planus, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Oral Lichen Planus
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Oct 2016to 26 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patient is 16 years old or over
- Patient is willing and able to provide valid informed consent
- Patient is attending the Oral Lichen Planus clinic and will be having a routine clinical biopsy taken
Who cannot join
- Patient under 16 years old
- Patient is immunocompromised
- Patients with comorbid disease state e.g. other inflammatory disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Dental Hospital and School of Dentistry
Birmingham, West Midlands, B5 7EG
About this study
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:
- 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.
- 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).
- 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.
- 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.
- 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?
- Conditions
- Oral Lichen Planus
- Medical subject headings
- Lichen Planus, Oral
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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
Measured: 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
Measured: 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?
Measured: 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?
Measured: Through study completion, (maximum 12 months from the defined end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start26 Oct 2016
- Primary completion26 Feb 2023
- Study completion26 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Landini, Phd, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289233
- Sponsor's protocol ID
- RG_15-112
- Status last verified
- Apr 2021
- First submitted
- 31 Jan 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular & Cellular Characterisation of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT04289233
- Acronym / sponsor ID
- RG_15-112
- Conditions
- Oral Lichen Planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 26 Feb 2023 (actual)
- Study completion
- 26 Feb 2023 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
- 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.
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patient is 16 years old or over
- Patient is willing and able to provide valid informed consent
- Patient is attending the Oral Lichen Planus clinic and will be having a routine clinical biopsy taken
Key exclusion criteria (3 listed)
- Patient under 16 years old
- Patient is immunocompromised
- Patients with comorbid disease state e.g. other inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histological architecture
Time frame: Through 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 lesions
Time frame: Through 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 classifications
Time frame: Through 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 features
Time frame: Through 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 markers
Time frame: Through 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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Landini, Phd principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological architecture (time frame: Through study completion, (maximum 12 months from the defined end of study)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.