Oral Lichen Planus and Systemical Oncological Comorbidities

NCT06449248 | Completed

• 1 other identifier: Lichen-Cancer
• Study Type: observational
• Target: 1,517
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oral Lichen Planus

Keywords

Oral Lichen Planus; Cancer; Retrospective; Multicenter

Outcome Measures

Primary Outcomes (1)

• Presence of any other tumor

  Researchers will check patient's clinical records looking for any type of tumor

  After the enrollment phase (during the subsequent month)

Secondary Outcomes (2)

• OLP Form and systemic cancer

  After the enrollment phase (during the subsequent six months)

• Lifestyle habits and/or infections and systemic tumors

  After the enrollment phase (during the subsequent six months)

Study Arms (2)

Case 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

Other: Checking of appropriateness of OLP diagnosis

Control Group

1. Patients of both sexes, consecutively enrolled in a 1:2 ratio 2. Age over 18 yo

Interventions

Checking of appropriateness of OLP diagnosis OTHER

The above mentioned interventions will be carried out through the accurate analysis of patients' clinical records

Also known as: Checking the presence of any tumor in any body district

Case Group

Eligibility Criteria

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

Study Population

The study will enroll patients previously treated at the General Dentistry and Orthodontic Outpatient Clinics of the promoter center ("Agostino Gemelli" Teaching Hospital) and associated centers.

You may qualify if:

• Patients of both sexes, consecutively enrolled in a 1:2 ratio
• Age over 18 yo
• Previous clinical and histological diagnosis of OLP

You may not qualify if:

• \. Age under 18 yo
• Patients of both sexes, consecutively enrolled in a 1:2 ratio
• Age over 18 yo
• Age under 18 yo
• Previous clinical and histological diagnosis of OLP

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Roma, 00168, Italy

Location

Related Publications (1)

• Gioco 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. 2025 Nov 24. doi: 10.1111/odi.70152. Online ahead of print.

  PMID: 41286554 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Romeo Patini, Univ. Res.

  Catholic University of Sacred Heart - Rome

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: January 2, 2023
• Primary Completion: October 2, 2023
• Study Completion: December 2, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available from the beginning of the enrollment phase until the end of the study.
• Access Criteria: Upon request to the PI

Locations

IT (1)