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

ClinicalTrials.gov ID

NCT04858100

Lead Sponsor

University of MilanOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

310Estimated

Last Update Posted

Mar 7, 2024Actual

Start Date

Sep 1, 2020Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Mar 1, 2026Estimated

Official Title

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

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.

• Leukoplakia, Oral

• Surgical excision of the lesion
• Wait and see approach

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University of MilanOTHER

giovanni.lodi@unimi.it003950319021

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