Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule

Study Overview
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Brief Summary
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The goal of this observational study is to learn about survival and prognostic factors in patients who underwent surgical treatment for primary squamous cell carcinoma of the nasal vestibule. The main questions it aims to answer are: what is the prognosis of patients affected by squamous cell carcinoma of the nasal vestibule? are there any specific factors that could influence prognosis? is it possible to elaborate a new staging system, able to overcome the limitations of the currently used ones? Data about patients, tumour and type of surgery performed will be collected. Participants will be followed-up for a minimum 6 months period after surgery.

Detailed Description
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This study will address the survival of patients with squamous cell carcinoma of the nasal vestibule (NV-SCC), and it will analyze factors influencing it. In particular, apart from demographic features of the patient, data regarding the origin of the tumour and its extension will be collected and the lesion will be restaged according the the three classification systems used at present (Wang's classification, AJCC for nasal cavity cancers, AJCC for non-melanomatous skin cancer of head and neck region), given the current controversy regarding the best staging system. Furthermore data related to the surgery and the final histology will be collected. All collected data will be analyzed in order to investigate any possible factor related to overall survival, disease specific survival and disease free survival. Patients will be followed for a minimum of 6 months up to 5 years after surgery.

Official Title
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Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study

Conditions
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Nasal Vestibule Carcinoma, Rhinectomy, Nasal Vestibule, Squamous Cell Carcinoma

Intervention / Treatment
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* Procedure: Rhinectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of squamous cell carcinoma of the nasal vestibule underwent upfront surgical treatment with curative intent availability of clinical and radiological data for cT reassessment availability of histological samples for pT reassessment follow-up of at least 6 months after surgery. Exclusion Criteria: patients initially referred for disease persistence or recurrence patients affected by tumour involving the nasal vestibule but originating from other sites (eg. nasal cavities, skin of the nasal pyramid or upper lip)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nasal Vestibule Squamous Cell Carcinoma<br>Patients affected by primary squamous cell carcinoma of the nasal vestibule. Patients will be treated with upfront surgery according to the current practice and followed to identify any possible factor affecting prognosis. | Procedure: Rhinectomy<br>* Surgery will be performed according to extension of the tumour, i.e. local resection limited to the vestibule, partial rhinectomy, total rhinectomy, extended total rhinectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall Survival | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Survival | Disease Free Survival | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Survival | Disease Specific Survival | From time of enrollment to event (death, recurrence) up to 60 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Gender | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Age | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Site of origin of the tumour | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Subsites involved by the tumour | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | cT stage (according to TNM nasal cavities, Wang classification, TNM skin) | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | cN stage | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | pT stage (according to TNM nasal cavities, Wang classification, TNM skin) | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | pN stage (according to TNM nasal cavities, Wang classification, TNM skin) | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Grade | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Dimensions | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Depth of infiltration | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Perineural invasion | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Perivascular invasion | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Surgical margin status | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Surgical procedure | From time of enrollment to event (death, recurrence) up to 60 months. | 
| Factors influencing survival (demographics, tumour-related, surgery-related) | Adjuvant treatment | From time of enrollment to event (death, recurrence) up to 60 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal vestibule, squamous cell carcinoma, rhinectomy