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

C

Catholic University of the Sacred Heart

Status

Enrolling

Conditions

Oral Carcinoma in Situ
Oral Carcinoma
Oral Lichen Planus

Study type

Observational

Funder types

Other

Identifiers

NCT06934863
LPO_CMR

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

300 participants in 1 patient group

A cohort of patients affected by Oral lichen patients
Description:
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

Trial contacts and locations

1

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Central trial contact

Carlo Lajolo Associate Professor, DDS, MD, PhD; Carlo Lajolo Associate Professor, MD, DDS, PhD

Data sourced from clinicaltrials.gov

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