Clinical trial · Observational
Oral Lichen Planus and Systemical Oncological Comorbidities
Oral Lichen Planus and Systemical Oncological Comorbidities: Case-control Multicenter Observational Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lichen planus (LP) is a chronic mucocutaneous inflammatory disease of unknown etiology. In its oral variant, oral lichen planus (OLP) has a reported prevalence ranging from 0.5% to 2.2% in the general population. The disease typically occurs between the ages of 30 and 60. Although the pathogenetic mechanism and the triggering factor remain unknown, an immune-mediated pathogenesis and the role of factors such as stress, anxiety, diabetes, other autoimmune diseases, hypertension, intestinal pathologies, chronic liver diseases, hypercholesterolemia, infections have been hypothesized , contact with dental materials, tumors and genetic predisposition to cancer. Oral lichen planus is one of the potentially malignant disorders, showing a malignant transformation rate of 1.4%. A preliminary analysis conducted in our research center has shown a correlation between OLP and systemic tumors, both solid and haematological, involving areas not involved in lesions attributable to OLP. According to these data, the objective of the study is to evaluate whether there is an association between OLP and peripheral tumors, both solid and haematological. The primary objective will be to investigate the possible existence of a statistically significant association between OLP and the development of systemic oncological pathologies. Secondary objective will be to investigate the existence of an association between the various forms of OLP and specific oncological pathologies and to evaluate whether the presence of other systemic pathologies and lifestyle factors (diabetes, hypertension, chronic liver disease, smoking, alcohol, infection by HPV, HCV, etc ...) could influence such association (primary outcome). The objectives will be pursued through the analysis of data collected from the medical records of patients belonging to the General Dentistry and Orthodontic Outpatient Clinics at the "Agostino Gemelli" Teaching Hospital and in the Oral Pathology Outpatient Clinics of the other centers involved.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Lichen Planus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Checking of appropriateness of OLP diagnosis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case Group
- description
- 1. Patients of both sexes, consecutively enrolled in a 1:2 ratio 2. Age over 18 yo 3. Previous clinical and histological diagnosis of OLP
- interventionNames
- Other: Checking of appropriateness of OLP diagnosis
- label
- Control Group
- description
- 1. Patients of both sexes, consecutively enrolled in a 1:2 ratio 2. Age over 18 yo
Primary outcomes (1)
- measure
- Presence of any other tumor
- timeFrame
- After the enrollment phase (during the subsequent month)
- description
- Researchers will check patient's clinical records looking for any type of tumor
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Study Group): 1. Patients of both sexes, consecutively enrolled in a 1:2 ratio 2. Age over 18 yo 3. Previous clinical and histological diagnosis of OLP Exclusion Criteria (Study Group): 1\. Age under 18 yo Inclusion Criteria (Control Group): 1. Patients of both sexes, consecutively enrolled in a 1:2 ratio 2. Age over 18 yo Exclusion Criteria (Control Group): 1. Age under 18 yo 2. Previous clinical and histological diagnosis of OLP
References
Publications (1)
- DERIVEDGioco G, Schiavelli A, Majorana A, Bardellini E, Abati S, Sardella A, Spadari F, Pellegrini M, Lauritano D, Borgia R, Pentenero M, Sutera S, Arduino PG, Gambino A, Broccoletti R, Biasotto M, Ottaviani G, Azzi L, D'Aiuto A, Gissi DB, Gabusi A, Santarelli A, Mascitti M, Vescovi P, Bortolotti G, Manfredi M, Meleti M, Zino G, Romeo U, Tenore G, Favia G, Limongelli L, Petruzzi M, Dimilito F, Lo Muzio L, Bizzoca ME, Campisi G, Panzarella V, Leuci S, Serpico R, Lucchese A, Colella G, Oteri G, Marciano A, Isola G, Polizzi A, Giudice A, Calabria E, Mariani U, Adamo D, Canfora F, Graziani F, Nisi M, Giuliani M, Ritrovato L, De Micheli F, Rupe C, Scilla F, Patini R, Cordaro M, Mignogna MD, Lajolo C; SIPMO (Italian Society of Oral Pathology and Medicine). Association Between Oral Lichen Planus and Non-Oral Cancers: A Multicentre Case-Control SIPMO Study. Oral Dis. 2026 Apr;32(4):1054-1067. doi: 10.1111/odi.70152. Epub 2025 Nov 24. PMID 41286554