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

NCT06934863 | Recruiting

• 1 other identifier: LPO_CMR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Lichen Planus; Oral Carcinoma; Oral Carcinoma in Situ

Keywords

Oral Lichen Planus; Malignant Transformation; Oral Carcinoma; Oral Dysplasia

Outcome Measures

Primary Outcomes (1)

• Number of Oral Carcinomas

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

  From January 2024 to January 2028

Study Arms (1)

A cohort of patients affected by Oral lichen patients

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A cohort of patients affected by oral lichen planus

You may qualify if:

• Clinical-histological diagnosis of Oral lichen planus
• Patients who gave consensus to personal data treatment
• Minimum 6 months follow-up

You may not qualify if:

• 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)

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart

Roma, Italy, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Carlo Lajolo Associate Professor, DDS, MD, PhD

CONTACT

3356078354; carlo.lajolo@unicatt.it

Carlo Lajolo Associate Professor, MD, DDS, PhD

CONTACT

3356078354; carlo.lajolo@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: April 18, 2025
• Study Start: January 31, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)