Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.

NCT07151014 | Not Yet Recruiting

• 1 other identifier: 7635
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to evaluate the cardiovascular profile and the risk of thrombotic events in patients affected by Oral Lichen Planus.

Conditions

Oral Lichen Planus

Keywords

oral lichen planus; Prothrombotic risk; trombophilia screening

Outcome Measures

Primary Outcomes (1)

• Prothrombotic risk evaluation

  Primary Outcome Measure 1 Title: Prevalence of Natural Anticoagulant Deficiency * Description: Proportion of patients with Oral Lichen Planus (OLP) showing reduced functional activity of at least one natural anticoagulant (antithrombin III, protein C, or protein S) below the laboratory reference range, measured in plasma samples. * Time Frame: From September 2025 to September 2026 * Unit of Measure: Percentage of participants with abnormal result (%). Primary Outcome Measure 2 Title: Prevalence of Antiphospholipid Antibody Positivity * Description: Proportion of OLP patients with positive antiphospholipid antibodies, defined as anticardiolipin IgG and/or IgM and/or anti-β2-glycoprotein I IgG/IgM above the laboratory cut-off, measured in serum. * Time Frame: From September 2025 to September 2026 * Unit of Measure: Percentage of participants with abnormal result (%).

  From September 2025 to September 2026

Interventions

blood sample collection OTHER

blood sample collection in old patients in order to study the trombophilic risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by oral lichen planus

You may qualify if:

• Patients with a clinical and histological diagnosis of Oral Lichen Planus
• Age \> 18 years
• Patients who agree to sign the informed consent form

You may not qualify if:

• Patients under 18 years of age
• Patients who do not agree to sign the informed consent form
• Patients without a diagnosis of Oral Lichen Planus
• Patients with previously known cardiac diseases
• History of major cardiovascular events (myocardial infarction, ischemic stroke, TIA)
• Patients with overt heart failure (NYHA class III-IV)
• Cardiomyopathies not related to the studied risk factors (e.g., genetic hypertrophic cardiomyopathy)
• Patients undergoing anticoagulant therapy
• Patients with primary or secondary conditions associated with increased cardiovascular risk

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: September 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: January 12, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share