Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06449248 |
| Other study ID # |
Lichen-Cancer |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2023 |
| Est. completion date |
December 2, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
Catholic University of the Sacred Heart |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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 has been hypothesized and the role of some factors such as
stress, anxiety, diabetes, other autoimmune diseases, hypertension, intestinal diseases,
chronic liver diseases, hypercholesterolemia, infections, contact with dental materials,
tumors and genetic predisposition to cancer.
Oral lichen planus typically has six clinical forms, classified as reticular, erosive,
atrophic, plaque, papular, and bullous. The various forms can coexist in a single patient
and/or can change over time.
About two-thirds of patients with OLP report oral symptoms that can range from burning to
pain. Oral pain is associated in most cases with atrophic or erosive lesions, while other
oral symptoms such as burning, xerostomia, and altered taste may be exacerbated by changes in
the oral mucosal surface at the lesions' site.
Oral lesions can persist for many years and symptoms and are characterized by periods of
quiescence and exacerbation, generally associated with an increase in erythematous and/or
ulcerative lesions with consequent pain and hypersensitivity. Patients with quiescent forms,
predominantly keratotic and plaque, are generally asymptomatic.
Corticosteroids, applied topically to lesions or administered systemically, are the most
widely used group of drugs. The reason for their use is the ability to modulate inflammation
and the immune response.
Forms that do not respond to corticosteroid therapy can be treated with immunosuppressive
drugs, such as cyclosporine.
The use of antifungals in association with corticosteroid treatment allows for an improvement
in the lesions, if they were already overinfected by C. Albicans, and prevents excessive
proliferation that could result from the use of corticosteroids.
OLP is one of the potentially malignant disorders, showing a malignant transformation rate of
1.4%.
It is now known that lesions ascribable to OLP, as an expression of a potentially malignant
disorder, can turn into neoplasms over time.
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 this evidence, the aim of the study is to assess whether there is an association
between OLP and distant 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.
This analysis will be performed on a group of patients affected by OLP compared with a group
of patients without OLP.
Secondary objective will be to investigate the possible existence of an association between
the different clinical forms of OLP and specific oncological pathologies; furthermore,
additional secondary objectives will be to investigate whether the association between OLP
and systemic tumors can be influenced by lifestyle factors, such as smoking and alcohol use,
and/or by the presence of other systemic diseases (diabetes, hypertension, chronic liver
disease , smoking, alcohol, HPV, HCV infection, etc.) 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.
