Clinical trial NCT05693116: Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
Official title: Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasal Vestibule Carcinoma
Rhinectomy
Nasal Vestibule
Squamous Cell Carcinoma
Keywords: nasal vestibule
squamous cell carcinoma
rhinectomy
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by primary squamous cell carcinoma of the nasal vestibule.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Survival
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Survival
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Survival
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
Secondary outcomes:
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
measure: Factors influencing survival (demographics, tumour-related, surgery-related)
timeFrame: From time of enrollment to event (death, recurrence) up to 60 months.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
state: Touluse
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
city: Cagliari
country: Italy
facility: Cagliari University Hospital
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
city: Varese
country: Italy
facility: Varese University Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Fabio Ferreli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreli F, Pirola F, Di Santo D, De Virgilio A, Spriano G, Mercante G. A critical analysis of the classifications of squamous cell carcinoma of the nasal vestibule. Oral Oncol. 2022 Jun;129:105880. doi: 10.1016/j.oraloncology.2022.105880. Epub 2022 Apr 28. No abstract available.
citation: Lambertoni A, Cherubino M, Battaglia P, De Col A, Giovannardi M, Antognoni P, Valdatta L, Karligkiotis A, Bignami M, Castelnuovo P, Turri-Zanoni M. Squamous Cell Carcinoma of Nasal Vestibule and Pyramid: Outcomes and Reconstructive Strategies. Laryngoscope. 2021 Apr;131(4):E1198-E1208. doi: 10.1002/lary.29107. Epub 2020 Oct 2.
citation: Chabrillac E, Talawdekar A, Garikipati S, Varley I, Sionis S, Beasley N, Jackson R. A single centre's experience of 23 cases of total rhinectomy for the treatment of squamous cell carcinoma involving the nasal vestibule. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):2069-2075. doi: 10.1007/s00405-021-06972-6. Epub 2021 Jul 5.