Condition category
Digestive System
Date applied
11/11/2019
Date assigned
28/11/2019
Last edited
28/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Prof Paolo G Arduino

ORCID ID

http://orcid.org/0000-0002-8798-7834

Contact details

Via Nizza 230
Turin
10126
Italy
00390116331522
paologiacomo.arduino@unito.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

DSarduino15

Study information

Scientific title

A randomized no intervention-controlled trial of surgery in oral leukoplakia with no dysplasia

Acronym

SurOL

Study hypothesis

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

Approved 07/01/2009, CIR-Dental School (Via Nizza 230, Turin, 10126, Italy; segr_cirdental@unito.it), ref: AP-RB2009/1234

Study design

Two arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measure

Malignant transformation of the biopsied lesion measured using visual inspection by a physician every six months

Secondary outcome measures

Progression of the disease measured using visual inspection by a physician every six months

Overall trial start date

01/01/2012

Overall trial end date

01/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

01/01/2012

Recruitment end date

30/12/2014

Locations

Countries of recruitment

Italy

Trial participating centre

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

Sponsor information

Organisation

University of Turin

Sponsor details

Via Nizza 230
Turin
10126
Italy
+39 (0)116331522
paologiacomo.arduino@unito.it

Sponsor type

University/education

Website

http://www.dentalschool.unito.it

Funders

Funder type

University/education

Funder name

Università degli Studi di Torino

Alternative name(s)

University of Turin, UNITO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/11/2019: Trial’s existence confirmed by CIR-Dental School