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

Last updated: April 12, 2025
Sponsor: Catholic University of the Sacred Heart
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Genitourinary Cancer

Precancerous Condition

Treatment

N/A

Clinical Study ID

NCT06934863
LPO_CMR
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical-histological diagnosis of Oral lichen planus

  • Patients who gave consensus to personal data treatment

  • Minimum 6 months follow-up

Exclusion

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 OSCCpatients with a OLP background were excluded)

Study Design

Total Participants: 300
Study Start date:
January 31, 2024
Estimated Completion Date:
January 31, 2029

Study 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.

Connect with a study center

  • Catholic University of the Sacred Heart

    Roma, 00168
    Italy

    Active - Recruiting

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