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

NCT ID: NCT04858100

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2026-03-01

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.

Conditions

Leukoplakia, Oral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Surgery

Each patient will receive the surgical excision of the lesion and subsequent follow-up

Group Type: EXPERIMENTAL

Surgical excision of the lesion

Intervention Type: PROCEDURE

The surgical removal of the lesion, performed within 3 months from the final diagnosis, will follow these steps:

• local anesthesia
• excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having at least 2 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.

Wait and see

Each patient will receive clinical follow-up of the lesion with periodical incisional tissue biopsy.

Group Type: ACTIVE_COMPARATOR

Wait and see approach

Intervention Type: OTHER

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.

In case of OSCC onset during the first 3 months after the final diagnosis, the patient will be excluded since the oral cancer occurence will be considered as a misdiagnosis, more than a "true" malignat progression.

Interventions

Surgical excision of the lesion

The surgical removal of the lesion, performed within 3 months from the final diagnosis, will follow these steps:

• local anesthesia
• excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having at least 2 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.

Intervention Type: PROCEDURE

Wait and see approach

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.

In case of OSCC onset during the first 3 months after the final diagnosis, the patient will be excluded since the oral cancer occurence will be considered as a misdiagnosis, more than a "true" malignat progression.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Lodi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Lodi, PhD, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

Università degli Studi di Torino Dental School

Turin, TO, Italy

Site Status: RECRUITING

University of Milan

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Lodi, PhD, DMD

Role: CONTACT

giovanni.lodi@unimi.it

00390250319021

Facility Contacts

Paolo Arduino, DDS

Role: primary

paologiacomo.arduino@unito.it

Paolo Arduino, DDS

Role: backup

Giovanni Lodi

Role: primary

giovanni.lodi@unimi.it

003950319021

Other Identifiers

LEUKO2020

Identifier Type: -

Identifier Source: org_study_id