Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Leukoplakia

Leukoplakia, Oral

Precancerous Conditions

Pathological Conditions, Anatomical

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Oral Leukoplakia

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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

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

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.

Surgical excision of the lesion

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.

Wait and see approach

Giovanni Lodi, PhD, DMD

Paolo Arduino, DDS

Giovanni Lodi

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.

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.

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

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

Number of patients who will develop oral squamous cell carcinoma

Period of time required to develop malignancy

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.

University of Milan

Associate Professor

Skin and Connective Tissue Diseases

Carcinoma, Squamous Cell

Keratosis

Hyperplasia

Disease Progression

Erythroplasia

Oral Squamous Cell Carcinoma

Erythroplakia

No evidence of dysplasia

Mild dysplasia

Moderate dysplasia

Severe dysplasia

Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer

Standard of Care Histopathology

Assessment for risk of progression to oral cancer

STRATICYTE Assessment

Jason Hwang, PhD

Mark Darling, MSc, MChD

Tim McGaw, DDS, MSc, MD

The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral lesions.

Background: The standard of care for potentially premalignant oral epithelial lesion (PPOEL) risk assessment for progression to cancer is dysplasia grading by histopathology. With significant overlap between dysplasia grades and high inter- and intra-observer variations, dysplasia grading alone has been shown to be inadequate as a prognostic tool. To investigate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in the early diagnosis of invasive oral cancer, a prospective multi-center observational study was designed with specimens obtained from community-based practices.

Methods: Patients that qualify to enroll in the study will be assessed for both standard of care histopathological assessment for dysplasia grade and STRATICYTE risk assessment, and followed for up to 60 months (from initial biopsy) to determine the outcome of their oral lesion(s).

Formalin-fixed paraffin-embedded tissue sections stained with H\&E and S100A7

Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment

A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE

Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk

Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach	NCT04858100	Leukoplakia, Or...	Surgical excisi... Wait and see ap...	18 Years -	University of Milan
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment	NCT04622462	Oral Neoplasm	Standard of Car... STRATICYTE Asse...	15 Years - 90 Years	Proteocyte Diagnostics Inc.

Spots Global Cancer Trial Database for oral potentially malignant disorder