Clinical trial NCT04858100: Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach
Official title: Comparison Between Surgical Excision and "Wait and See" Approach in the Treatment of Oral Leukoplakia: a Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukoplakia, Oral
Keywords: Oral Potentially Malignant Disorder
Oral carcinoma
Oral medicine
Cancer prevention
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 reducing the onset of potential oral squamous cell carcinoma, with a follow-up of 5 years. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral cancer incidence
timeFrame: every 3 or 6 months (according to the clinical case) up to 5 years
Secondary outcomes:
measure: Time to malignant transformation from diagnosis
timeFrame: every 3 or 6 months (according to clinical case) up to 5 years
measure: Quality of life after surgical excision
timeFrame: month 1 and month 6
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Università degli Studi di Torino Dental School
state: TO
city: Milan
country: Italy
facility: University of Milan
Study officials:
affiliation: University of Milan
name: Giovanni Lodi, PhD, DMD
role: PRINCIPAL_INVESTIGATOR
References: