Risk of oral cancer in patients with oral lichen planus (a rash that can affect the inside of the mouth)

ISRCTN ISRCTN47966874
DOI https://doi.org/10.1186/ISRCTN47966874
Submission date
27/07/2021
Registration date
28/09/2021
Last edited
04/01/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Oral lichen planus (OLP) is a rash that can affect different parts of your body, including the inside of your mouth. The most critical but possible complication of OLP is the development of mouth cancer, although this is a very controversial matter. At the end of the 80s, our group started to collect data to estimate the potential risk of malignant transformation in a Northern Italian cohort of OLP patients, and we published the first results in late 2004. In this new manuscript we finally reported our evaluation after 33 years of observation. To the best of our knowledge, this is the largest number of OLP patients ever reported with such follow-up period. Based on these results, the current concepts for malignant potential of Northern Italian OLP has been critically analysed.

Who can participate?
Patients with OLP that attended a single hospital in Northern Italy between 1998 and 2020.

What does the study involve?
Patient records will be analysed to find out if OLP led to cancer.

What are the possible benefits and risks of participating?
None

Where is the study run from?
CIR-Dental School, University of Turin (Italy)

When is the study starting and how long is it expected to run for?
January 1988 to December 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof Arduino, paologiacomo.arduino@unito.it

Contact information

Prof Paolo G Arduino
Scientific

Via Nizza 230
Turin
10126
Italy

ORCiD logoORCID ID 0000-0002-8798-7834
Phone +39 (0)116331522
Email paologiacomo.arduino@unito.it

Study information

Study designPopulation-based cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not applicable (retrospective study)
Scientific titleMalignant transformation in subjects with oral lichen planus (OLP): a 33-year cohort study in Northern Italy.
Study acronymCandOLP
Study hypothesisOLP is at risk for developing oral cancer in the follow-up period.
Ethics approval(s)The study was approved by the ethical review board of the CIR-Dental School, University of Turin (CIR-PO-pga2020/09) which did not necessitate informed consent because of the nature of the study.
ConditionOral lichen planus
InterventionThis study will involve the review of participants charts with OLP diagnosed between January 1988 and December 2020 at one hospital in Northern Italy.
Intervention typeOther
Primary outcome measurePercentage of the histopathological diagnosis of oral cancer in OLP patients measured using patient records at a single time point
Secondary outcome measuresMeasured using patient records at a single time point:
1. The tumour site
2. T classification and neck nodes association
3. Treatment modalities
4. Outcome and survival rate
Overall study start date01/01/1988
Overall study end date31/12/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants3,000
Total final enrolment3173
Participant inclusion criteriaConclusive diagnosis of OLP based on the following criteria:
1. Clinical confirmation with the presence of characteristic bilateral clinical signs [papular and/or reticular lesions (Wickham striae) alone or in association with atrophic or erosive lesions], not related to oral amalgam restorations;
2. Histological confirmation, through incisional biopsy, demonstrating the following microscopic characteristic:
2.1. Presence of a well-defined band-like zone of cellular infiltration that is confined to the superficial part of the connective tissue, consisting mainly of lymphocytes
2.2. Signs of “liquefaction degeneration” in the basal cell layer
2.3. Lack of epithelial dysplasia
Participant exclusion criteria1. Unable or unwilling to provide informed consent
2. Significant psychiatric or cognitive impairment
Recruitment start date01/01/1988
Recruitment end date01/06/2020

Locations

Countries of recruitment

  • Italy

Study participating centre

CIR-Dental School
University of Turin
Via Nizza 230
Turin
10126
Italy

Sponsor information

University of Turin
University/education

CIR Dental School
Via Nizza 230
Turin
10126
Italy

Phone +39 (0)116331522
Email roberto.broccoletti@unito.it
Website https://www.dentalschool.unito.it/it
ROR logo "ROR" https://ror.org/048tbm396

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/12/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe results of the primary and secondary endpoints along with any other reportable data will be published in peer-review journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 16/11/2021 04/01/2022 Yes No

Editorial Notes

04/01/2022: Publication reference added.
04/08/2021: Trial's existence confirmed by ethical review board of the CIR-Dental School, University of Turin.