Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach

Study Overview
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Brief Summary
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This research protocol is comparing the effectiveness of surgical excision to the wait and see approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.

Detailed Description
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Different treatments have been proposed for the management of oral leukoplakia (OL) in order to prevent oral squamous cell carcinoma onset. However, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. Surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset. A recent RCT compared surgical treatment with wait and see approach care in patients with nondysplastic OL, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias. The purpose of this study is to evaluate effectiveness of surgical excision in treating OL and or prolonging the onset of potential oral squamous cell carcinoma. This study will be the first RCT comparing the effectiveness of surgery to wait and see approach in the management of both dysplastic and nondysplastic oral leukoplakias.

Official Title
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Comparison Between Surgical Excision and Wait and See Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial

Conditions
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Leukoplakia, Oral

Intervention / Treatment
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* Procedure: Surgical excision of the lesion
* Other: Wait and see approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OL diagnosis should be confirmed by incisional diagnostic biopsy and subsequent histopathological analysis Subjects' age: 18 years or older Lesions' size: 3 cm maximum longitudinal size of the single lesion Lesions's location: oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries. Ability to understand and to sign a written informed consent document Exclusion Criteria: Previous oral cancer Head and neck radiotherapy Subjects under the age of 18 Subjects affected by PVL (proliferative verrucous leukoplakia) High-risk of surgical damages to anatomical structures such as nerves, salivary ducts and/or arteries

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Each patient will receive the surgical excision of the lesion and subsequent follow-up | Procedure: Surgical excision of the lesion<br>* The surgical removal of the lesion will follow these steps: local anesthesia excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having 5 mm-free margins silk or resorbable suture for wound closure The patient will be recall after 14 days for assessing the wound healing and after 30 days for providing and explaining him the histopahtological exam. The patient will receive a 3-6 month follow-up according to the clinical and histopathological case.<br>|
| Active Comparator: Wait and see<br>Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy. | Other: Wait and see approach<br>* The patient will receive a 3-6 month follow-up according to the clinical and histopathological case, with periodical incisional biopsy every 4 control visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral cancer incidence | Number of patients who will develop oral squamous cell carcinoma | every 3 or 6 months (according to the clinical case) up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to malignant transformation from diagnosis | Period of time required to develop malignancy | every 3 or 6 months (according to clinical case) up to 5 years | 
| Quality of life after surgical excision | To evaluate the quality of life of patients affected by leukoplakia and treated with surgical excision, via Functional Intraoral Glasgow Scale (FIGS) questionnaire. FIGS is a simple point scale used to assess a patient's ability to speak, chew and swallow. Each of these functions is scored independently on a scale of 1-5, five being no disability and one meaning the patient has an inability to speak, chew, or swallow. | month 1 and month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Potentially Malignant Disorder, Oral carcinoma, Oral medicine, Cancer prevention