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临床试验/NCT04289233
NCT04289233已完成不适用

Molecular & Cellular Characterisation of Oral Lichen Planus

University of Birmingham1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Histological architecture

研究概览

简要总结

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.

详细描述

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?

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patient under 16 years old
  • Patient is immunocompromised
  • Patients with comorbid disease state e.g. other inflammatory disease

结局指标

主要结局

Histological architecture

时间窗: 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?

Molecular expression of Oral Lichen Planus markers

时间窗: 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?

Statistical classifications

时间窗: 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

时间窗: Through study completion, (maximum 12 months from the defined end of study)

Is it possible to automate such morphometrical analysis/classification?

Comparisons with other dysplastic lesions

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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