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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05693116
Acronym
NV-SCC
Enrollment
300
Registered
2023-01-20
Start date
2022-12-01
Completion date
2029-12-31
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

nasal vestibule, squamous cell carcinoma, rhinectomy

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.

Interventions

PROCEDURERhinectomy

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

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
SurvivalFrom time of enrollment to event (death, recurrence) up to 60 months.Overall Survival

Secondary

MeasureTime frameDescription
Factors influencing survival (demographics, tumour-related, surgery-related)From time of enrollment to event (death, recurrence) up to 60 months.Gender

Countries

France, Italy, United Kingdom

Contacts

Primary ContactFrancesca Pirola, MD
francesca.pirola@humanitas.it00390282243557
Backup ContactDavide Di Santo, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026