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

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

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 Overview

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

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Carlo Lajolo Associate Professor, DDS, MD, PhD; Phone Number: +39 3356078354; Email: carlo.lajolo@unicatt.it
• Study Contact Backup: Name: Carlo Lajolo Associate Professor, MD, DDS, PhD; Phone Number: +39 3356078354; Email: carlo.lajolo@unicatt.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Catholic University of the Sacred Heart
    • Contact: Carlo Lajolo Associate Professor, MD, DDS, PhD; Phone Number: +39 3356078354; Email: carlo.lajolo@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A cohort of patients affected by oral lichen planus

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Oral Carcinomas	Number of cases that will be histologically diagnosed as Oral Carcinomas. This outcome will be expressed as a dichotomous variable (i.e., yes/no).	From January 2024 to January 2028

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: April 12, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Oral Lichen Planus; Malignant Transformation; Oral Carcinoma; Oral Dysplasia
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lichen Planus; Lichen Planus, Oral; Mouth Neoplasms
• Other Study ID Numbers: LPO_CMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No