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

Recruiting

• Conditions: Rhinectomy; Nasal Vestibule; Squamous Cell Carcinoma; Nasal Vestibule Carcinoma
• Interventions: Procedure: Rhinectomy

• Registration Number: NCT05693116
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-08
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nasal Vestibule Squamous Cell Carcinoma	Rhinectomy	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.

Primary Outcome Measures

Name	Time	Method
Survival	From time of enrollment to event (death, recurrence) up to 60 months.	Disease Specific Survival

Secondary Outcome Measures

Name	Time	Method
Factors influencing survival (demographics, tumour-related, surgery-related)	From time of enrollment to event (death, recurrence) up to 60 months.	Adjuvant treatment

Trial Locations

Locations (6)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, Touluse, France

Cagliari University Hospital; 🇮🇹 Cagliari, Italy

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy

Varese University Hospital; 🇮🇹 Varese, Italy

Sheffield Teaching Hospital NHS Foundation Trust; 🇬🇧 Sheffield, United Kingdom