Evaluating the risk of cancer in patients with oral lichen planus
Observational Study of an OLP Patients Cohort: Characteristics, Comorbidities, Risk Factors for Malignant Transformation
Catholic University of the Sacred Heart · NCT06934863
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart (other) |
| Locations | 1 site (Roma, Italy) |
| Trial ID | NCT06934863 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there have been studies on oral lichen planus, this specific focus on malignant transformation rates and risk factors is relatively novel.
Eligibility criteria
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 this trial is running
Roma, Italy
- Catholic University of the Sacred Heart — Roma, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Carlo Lajolo Associate Professor, DDS, MD, PhD
- Email: carlo.lajolo@unicatt.it
- Phone: 3356078354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Lichen Planus, Oral Carcinoma, Oral Carcinoma in Situ, Malignant Transformation, Oral Dysplasia