Clinical trial NCT06934863: Rate of Malignant Transformation and Clinical Characteristics Among an Oral Lichen Planus Cohort: a Retrospective Center Experience
Official title: Observational Study of an OLP Patients Cohort: Characteristics, Comorbidities, Risk Factors for Malignant Transformation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Lichen Planus
Oral Carcinoma
Oral Carcinoma in Situ
Keywords: Oral Lichen Planus
Malignant Transformation
Oral Carcinoma
Oral Dysplasia
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of patients affected by oral lichen planus

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Oral Carcinomas
timeFrame: From January 2024 to January 2028
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
References: