Oral Lichen PlanusNCT06449248
Oral Lichen Planus and Systemical Oncological Comorbidities
An observational study of Oral Lichen Planus, run by Catholic University of the Sacred Heart at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Checking of appropriateness of OLP diagnosis
- How many people
- 1,517 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2023to 2 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients of both sexes, consecutively enrolled in a 1:2 ratio
- Age over 18 yo
- Previous clinical and histological diagnosis of OLP
- Patients of both sexes, consecutively enrolled in a 1:2 ratio
- Age over 18 yo
Who cannot join
- 1. Age under 18 yo
- Age under 18 yo
- Previous clinical and histological diagnosis of OLP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Lichen Planus and Systemical Oncological Comorbidities: Case-control Multicenter Observational Clinical Study
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.
Read more
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.
Read the 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 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.
- Conditions
- Oral Lichen Planus
- Being tested
- Checking of appropriateness of OLP diagnosis
- Keywords
- Oral Lichen Planus, Cancer, Retrospective, Multicenter
- Medical subject headings
- Lichen Planus, Oral, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checking of appropriateness of OLP diagnosisOther
Also called Checking the presence of any tumor in any body district
The above mentioned interventions will be carried out through the accurate analysis of patients' clinical records
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of any other tumor
Researchers will check patient's clinical records looking for any type of tumor
Measured: After the enrollment phase (during the subsequent month)
Secondary outcomes (2)
OLP Form and systemic cancer
Evaluation of the association between a specific OLP clinical form and the development of systemic cancers
Measured: After the enrollment phase (during the subsequent six months)
Lifestyle habits and/or infections and systemic tumors
Evaluation of the association between specific lifestyle factors and/or infections and the development of systemic cancers
Measured: After the enrollment phase (during the subsequent six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start2 Jan 2023
- Primary completion2 Oct 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Lajolo, Catholic University of the Sacred Heart
- Investigators
- Romeo Patini, Univ. Res., Study chair, Catholic University of Sacred Heart - Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449248
- Sponsor's protocol ID
- Lichen-Cancer
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Design will be shared with other centers participating to the study.
Publications
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. 2026 Apr;32(4):1054-1067. doi: 10.1111/odi.70152. Epub 2025 Nov 24.
PubMed 41286554
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lichen Planus and Systemical Oncological Comorbidities: Case-control Multicenter Observational Clinical Study
- ClinicalTrials.gov ID
- NCT06449248
- Acronym / sponsor ID
- Lichen-Cancer
- Conditions
- Oral Lichen Planus
- Keywords
- Oral Lichen Planus, Cancer, Retrospective, Multicenter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,517 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Other: Checking of appropriateness of OLP diagnosis1. Patients of both sexes, consecutively enrolled in a 1:2 ratio 2. Age over 18 yo 3. Previous clinical and histological diagnosis of OLP |
| Control Group | – | –1. Patients of both sexes, consecutively enrolled in a 1:2 ratio 2. Age over 18 yo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patients of both sexes, consecutively enrolled in a 1:2 ratio
- Age over 18 yo
- Previous clinical and histological diagnosis of OLP
- Patients of both sexes, consecutively enrolled in a 1:2 ratio
- Age over 18 yo
Key exclusion criteria (3 listed)
- 1. Age under 18 yo
- Age under 18 yo
- Previous clinical and histological diagnosis of OLP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checking of appropriateness of OLP diagnosisAlso: Checking the presence of any tumor in any body districtThe above mentioned interventions will be carried out through the accurate analysis of patients' clinical records | Other | Case Group |
Primary outcome
Presence of any other tumor
Time frame: After the enrollment phase (during the subsequent month)
Researchers will check patient's clinical records looking for any type of tumor
2 secondary outcomes
OLP Form and systemic cancer
Time frame: After the enrollment phase (during the subsequent six months)
Lifestyle habits and/or infections and systemic tumors
Time frame: After the enrollment phase (during the subsequent six months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 41286554Gioco 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.
- Individual participant dataSharing planned: Yes. Study Design will be shared with other centers participating to the study.
Related trials for Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romeo Patini, Univ. Res. study chair
Catholic University of Sacred Heart - Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of any other tumor (time frame: After the enrollment phase (during the subsequent month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.