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

NCT ID: NCT06934863

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2029-01-31

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.

Conditions

Oral Lichen Planus; Oral Carcinoma; Oral Carcinoma in Situ

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Carlo Lajolo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of the Sacred Heart

Roma, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carlo Lajolo Associate Professor, DDS, MD, PhD

Role: CONTACT

carlo.lajolo@unicatt.it

3356078354 ext. +39

Carlo Lajolo Associate Professor, MD, DDS, PhD

Role: CONTACT

carlo.lajolo@unicatt.it

3356078354 ext. +39

Facility Contacts

Carlo Lajolo Associate Professor, MD, DDS, PhD

Role: primary

carlo.lajolo@unicatt.it

3356078354 ext. +39

Other Identifiers

LPO_CMR

Identifier Type: -

Identifier Source: org_study_id