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Clinical Trials/NCT06934863
NCT06934863RecruitingNot Applicable

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

Catholic University of the Sacred Heart1 site in 1 country300 target enrollmentStarted: January 31, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
Number of Oral Carcinomas

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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)

Arms & Interventions

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.

Outcomes

Primary Outcomes

Number of Oral Carcinomas

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carlo Lajolo

Associate Professor

Catholic University of the Sacred Heart

Study Sites (1)

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