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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Italy1 site
  • Catholic University of Sacred Heart

    Roma, 00168

Other trials in Italy

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.

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 groups in NCT06449248
Study groupRoleWhat they receive
Case Group1. 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 Group1. 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.

  1. 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)
  1. 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)

  2. 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.

  1. First posted7 Jun 2024
  2. Study start2 Jan 2023
  3. Primary completion2 Oct 2023
  4. Study completion2 Dec 2023

Resources

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)
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

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.

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