Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449248
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Oral Lichen Planus and Systemical Oncological Comorbidities
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Oral Lichen Planus and Systemical Oncological Comorbidities Case-control Multicenter Observational Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 to 22 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 14
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
In its oral variant oral lichen planus OLP has a reported prevalence ranging from 05 to 22 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 14
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
Detailed 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 05 to 22 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 andor 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 andor 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 14
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 andor 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
In its oral variant oral lichen planus OLP has a reported prevalence ranging from 05 to 22 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 andor 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 andor 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 14
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None