Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rhinectomy.
- Who it may be relevant to
- Registry conditions: Nasal Vestibule Carcinoma, Rhinectomy, Nasal Vestibule, Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study
Overview
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
- Procedure Rhinectomy
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
Primary outcome measures
- Survival [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Survival [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Survival [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
Secondary outcome measures (12)
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
- Factors influencing survival (demographics, tumour-related, surgery-related) [Time frame: From time of enrollment to event (death, recurrence) up to 60 months.]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 4 centers
- Humanitas Research Hospital — Rozzano
- Cagliari University Hospital — Cagliari
- IRCCS San Raffaele Hospital — Milan
- Varese University Hospital — Varese
France · 1 center
- Centre Hospitalier Universitaire de Toulouse — Toulouse
United Kingdom · 1 center
- Sheffield Teaching Hospital NHS Foundation Trust — Sheffield
Publications
- 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. PMID 35490569
- 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. PMID 33006408
- 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. PMID 34223976
Identifiers
NCT: NCT05693116 · 3273