SurOL: Surgery for oral leukoplakia (a white patch in the mouth)
| ISRCTN | ISRCTN12617344 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12617344 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | DSarduino15 |
| Sponsor | University of Turin |
| Funder | Università degli Studi di Torino |
- Submission date
- 11/11/2019
- Registration date
- 28/11/2019
- Last edited
- 02/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Leukoplakia is a white patch in the mouth. The WHO Collaborating Centres for Oral Precancerous conditions have clinically defined the term oral leukoplakia (OL) as “white mucosal lesions that have a risk of progressing to squamous carcinoma”. To date, the term OL should be used to recognize “predominantly white plaques of questionable risk having excluded (other) known diseases or disorders that carry no increased risk for cancer”. The vast majorities of OLs are localized lesions and follow a benign course. Small subsets of these lesions can become cancerous.
The aim of this study was to assess the effectiveness of surgery in the treatment of OL, in order to compare the "wait and see" approach in term of possible malignant transformation.
Who can participate?
Caucasian patients aged 18 years or above, with OL without signs of cancer
What does the study involve?
Participants will be randomly assigned to receive either surgical removal of the OL, or treatment as usual
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 2012 to December 2014
Who is funding the study?
Università degli Studi di Torino (University of Turin), Italy
Who is the main contact?
Prof. Paolo G. Arduino
paologiacomo.arduino@unito.it
Contact information
Public
Via Nizza 230
Turin
10126
Italy
 ORCID ID |
0000-0002-8798-7834 |
|---|---|
| Phone | 00390116331522 |
| paologiacomo.arduino@unito.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two arm randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomized no intervention-controlled trial of surgery in oral leukoplakia with no dysplasia |
| Study acronym | SurOL |
| Study objectives | The aim of this study is to evaluate the surgical outcome of patients diagnosed with an oral leukoplakia without dysplasia, compared to patients with the same diagnosis who did not undergo surgery |
| Ethics approval(s) | Approved 07/01/2009, CIR-Dental School (Via Nizza 230, Turin, 10126, Italy; segr_cirdental@unito.it), ref: AP-RB2009/1234 |
| Health condition(s) or problem(s) studied | Oral leukoplakia with no signs of dysplasia |
| Intervention | Consecutive Caucasian patients, attending the Oral Medicine Section of the Department of Surgical Sciences, Turin Hospital, Italy, from January 2012 and December 2013, are selected for the present study. Participants are randomly divided into two groups. Allocation to treatment arms is performed using sequentially numbered randomization table. RANCODE (version 3.6) is used to generate the randomization sequence. The first group of patients undergo surgical excision of the lesion with a traditional scalpel, (GROUP A_TS) whereas the second group of patients are followed up with no surgical session (GROUP B_NS). The period of follow up is 5 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Malignant transformation of the biopsied lesion measured using visual inspection by a physician every six months |
| Key secondary outcome measure(s) |
Progression of the disease measured using visual inspection by a physician every six months |
| Completion date | 01/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 260 |
| Key inclusion criteria | 1. Caucasian patients, attending the Oral Medicine Section of the Department of Surgical Sciences, Turin Hospital 2. Diagnosis of oral leukoplakia with no signs of dysplasia 3. Adults aged 18 and older |
| Key exclusion criteria | 1. Patients with a previous diagnosis of oral cancer. 2. Pregnant or lactating females; patients with incapacity to understand verbal and written instructions |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 30/12/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
Turin
10126
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2020 | 02/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
12/11/2019: Trial’s existence confirmed by CIR-Dental School
