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

Sponsor: University of Milan

Sommario: 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.

TIPOLOGIA STUDIO

Interventistico

FASE

Non Disponibile

TRATTAMENTO

• Surgical excision of the lesion
• Wait and see approach

OBIETTIVO PRIMARIO

• Misura: Oral cancer incidence
• Tempo: every 3 or 6 months (according to the clinical case) up to 5 years
• Descrizione: Number of patients who will develop oral squamous cell carcinoma

OBIETTIVO SECONDARIO

• Misura: Time to malignant transformation from diagnosis
• Tempo: every 3 or 6 months (according to clinical case) up to 5 years
• Descrizione: Period of time required to develop malignancy

• Misura: Quality of life after surgical excision
• Tempo: month 1 and month 6
• Descrizione: 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.

CRITERI DI ELIGIBILITA'

• Criteri di inclusione e esclusione

  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

SESSO

Tutti

ETA' MINIMA

Età Minima: 18 Years
Età Massima: N/A

LUOGO

University of Milan
Milan 3173435, 20142