Rate of Malignant Transformation and Clinical Characteristics Among an Oral Lichen Planus Cohort: a Retrospective Center Experience

Recruiting

• Conditions: Oral Lichen Planus; Oral Carcinoma; Oral Carcinoma in Situ

• Registration Number: NCT06934863
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study Start: 2024-01-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-04-12
• Last Update Submitted: 2025-04-12
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Primary Completion: 2028-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Oral Carcinomas	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).

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Roma, Italy