NCT06934863

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Lichen Planus
• Oral Carcinoma
• Oral Carcinoma in Situ

Timeline

• Start date: 2024-01-31
• Primary completion: 2028-01-31
• Completion: 2029-01-31
• First posted: 2025-04-18
• Last updated: 2025-04-18

Locations

1 site across 1 country: Italy