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临床试验/NCT06934863
NCT06934863招募中不适用

Observational Study of an OLP Patients Cohort: Characteristics, Comorbidities, Risk Factors for Malignant Transformation

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Number of Oral Carcinomas

研究概览

简要总结

The main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. Secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to OLP drgus.

详细描述

Oral Lichen Planus (OLP) is a chronic inflammatory mucocutaneous disease of unknown etiology, primarily affecting the oral mucosa. Global prevalence ranges from 1.01% to 3%, with an estimated 1.43% prevalence in Europe. Although OLP can affect the scalp, nails, and skin, it most commonly manifests in the oral cavity. The disease primarily involves the stratified squamous epithelium of the mouth, and while its precise cause remains unclear, it is thought to result from a T-cell-mediated autoimmune response, triggered by microbial agents, chemicals, stress, or viral infections. T cells directly attack keratinocytes, causing epithelial damage, with both specific (T-cell activity) and nonspecific mechanisms (MMPs, chemokines, and mast cells) contributing to disease progression. CD8+ and CD4+ T cells and Langerhans cells play key roles in antigen presentation, while Matrix Metalloproteinases (MMPs) and their inhibitors (TIMPs) are involved in the breakdown of the basement membrane, leading to keratinocyte destruction.

The main objective of this paper will be to evaluate the rate of malignant transformation among a cohort of patients affected by oral lichen planus with long-term follow-up. Secondary aims will be to study and describe the characteristics of these patients to identify potential risk factors for malignant transformation, and to evaluate the therapeutic effects and features to OLP drgus. Also, dental and periodontal status will be evaluated based on charts and charting data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Clinical-histological diagnosis of Oral lichen planus
  • •Patients who gave consensus to personal data treatment
  • •Minimum 6 months follow-up

排除标准

  • •Patients who did not give consensus to personal data treatment
  • •Oral lichenoid lesions
  • •Patients with anamnesis of hematopoietic stem cells transplant
  • •Patients with a OSCC at the first histological examination (i.e., namely: also OSCC patients with a OLP background were excluded)

研究组 & 干预措施

A cohort of patients affected by Oral lichen patients

A cohort of patients affected by Oral lichen patients will be evaluated retrospectively in anamnestic and clinical characteristics in order to assess any risk factors for malignant transformation. Also, dental and periodontal status will be evaluated based on charts and charting data.

结局指标

主要结局

Number of Oral Carcinomas

时间窗: From January 2024 to January 2028

Number of cases that will be histologically diagnosed as Oral Carcinomas. This outcome will be expressed as a dichotomous variable (i.e., yes/no).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Lajolo

Associate Professor

Catholic University of the Sacred Heart

研究点 (1)

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