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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Turin |
| Funder | Investigator initiated and funded |
- 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
Plain English summary of protocol
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
Scientific
Via Nizza 230
Turin
10126
Italy
 ORCID ID |
0000-0002-8798-7834 |
|---|---|
| Phone | +39 (0)116331522 |
| paologiacomo.arduino@unito.it |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Population-based cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Malignant transformation in subjects with oral lichen planus (OLP): a 33-year cohort study in Northern Italy. |
| Study acronym | CandOLP |
| Study objectives | OLP 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. |
| Health condition(s) or problem(s) studied | Oral lichen planus |
| Intervention | This study will involve the review of participants charts with OLP diagnosed between January 1988 and December 2020 at one hospital in Northern Italy. |
| Intervention type | Other |
| Primary outcome measure(s) |
Percentage of the histopathological diagnosis of oral cancer in OLP patients measured using patient records at a single time point |
| Key secondary outcome measure(s) |
Measured using patient records at a single time point: |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 3000 |
| Total final enrolment | 3173 |
| Key inclusion criteria | Conclusive 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 |
| Key exclusion criteria | 1. Unable or unwilling to provide informed consent 2. Significant psychiatric or cognitive impairment |
| Date of first enrolment | 01/01/1988 |
| Date of final enrolment | 01/06/2020 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Nizza 230
Turin
10126
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
