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NCT Number: NCT06934863

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Catholic University of the Sacred Heart

Roma, 00168, Italy

Location status: Recruiting

Location contact

Carlo Lajolo Associate Professor, MD, DDS, PhD

CONTACT

[email protected]

3356078354 ext. +39

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of Oral Carcinomas

    Time frame: From January 2024 to January 2028

    Number of cases that will be histologically diagnosed as Oral Carcinomas. This outcome will be expressed as a dichotomous variable (i.e., yes/no).

Study contacts

Contact information is provided by the study sponsor or research team.

Carlo Lajolo Associate Professor, DDS, MD, PhD

CONTACT

[email protected]

3356078354 ext. +39

Carlo Lajolo Associate Professor, MD, DDS, PhD

CONTACT

[email protected]

3356078354 ext. +39

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Acronym: LPO_CMR

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Apr 18, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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