Clinical trial Recruiting at 1 site Observational

Evaluating the risk of cancer in patients with oral lichen planus

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

Run by Catholic University of the Sacred Heart · NCT06934863 · Data updated 2026-11-12

This study is looking to see how often oral lichen planus turns into cancer in patients over time and what factors might increase that risk.

More Oral Lichen Planus trials

Quick facts

Study typeObservational
SexAll
Enrollment300 (estimated)
SponsorCatholic University of the Sacred Heart
Academic / other
Locations1 site (Roma)
StatusRecruiting
StartedJanuary 31, 2024
Main results expectedJanuary 31, 2028
Study endsJanuary 31, 2029
Registry record updatedMay 14, 2026
Trial IDNCT06934863 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals with a clinical-histological diagnosis of oral lichen planus who have consented to personal data treatment and have a minimum follow-up of six months.

Probably not a fit

Patients with oral lichenoid lesions or those who have a history of hematopoietic stem cell transplant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the rate of malignant transformation in patients diagnosed with oral lichen planus (OLP) over a long-term follow-up period. It will also explore the clinical characteristics of these patients to identify potential risk factors associated with malignant transformation. The study will analyze data from a cohort of patients to evaluate therapeutic effects and features related to OLP. By understanding these factors, the research seeks to provide insights into the management of OLP and its potential progression to oral carcinoma.

Why it matters

Potential benefit: If successful, this study could help identify patients at higher risk for malignant transformation, leading to improved monitoring and treatment strategies.

How similar studies have gone: While there have been studies on oral lichen planus, this specific focus on malignant transformation rates and risk factors is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • Catholic University of the Sacred Heart
    Roma, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.