NV-SCC: Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
Study Details
Study Description
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:
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what is the prognosis of patients affected by squamous cell carcinoma of the nasal vestibule?
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are there any specific factors that could influence prognosis?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Nasal Vestibule Squamous Cell Carcinoma 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
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
|
Outcome Measures
Primary Outcome Measures
- Survival [From time of enrollment to event (death, recurrence) up to 60 months.]
Overall Survival
- Survival [From time of enrollment to event (death, recurrence) up to 60 months.]
Disease Free Survival
- Survival [From time of enrollment to event (death, recurrence) up to 60 months.]
Disease Specific Survival
Secondary Outcome Measures
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Gender
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Age
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Site of origin of the tumour
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Subsites involved by the tumour
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
cT stage (according to TNM nasal cavities, Wang classification, TNM skin)
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
cN stage
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
pT stage (according to TNM nasal cavities, Wang classification, TNM skin)
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
pN stage (according to TNM nasal cavities, Wang classification, TNM skin)
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Grade
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Dimensions
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Depth of infiltration
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Perineural invasion
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Perivascular invasion
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Surgical margin status
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Surgical procedure
- Factors influencing survival (demographics, tumour-related, surgery-related) [From time of enrollment to event (death, recurrence) up to 60 months.]
Adjuvant treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of squamous cell carcinoma of the nasal vestibule
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underwent upfront surgical treatment with curative intent
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availability of clinical and radiological data for cT reassessment
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availability of histological samples for pT reassessment
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follow-up of at least 6 months after surgery.
Exclusion Criteria:
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patients initially referred for disease persistence or recurrence
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patients affected by tumour involving the nasal vestibule but originating from other sites (eg. nasal cavities, skin of the nasal pyramid or upper lip)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Toulouse | Toulouse | Touluse | France | |
| 2 | Humanitas Research Hospital | Rozzano | Milan | Italy | 20089 |
| 3 | Cagliari University Hospital | Cagliari | Italy | 09124 | |
| 4 | IRCCS San Raffaele Hospital | Milan | Italy | 20132 | |
| 5 | Varese University Hospital | Varese | Italy | 21100 | |
| 6 | Sheffield Teaching Hospital NHS Foundation Trust | Sheffield | United Kingdom |
Sponsors and Collaborators
- Istituto Clinico Humanitas
Investigators
- Principal Investigator: Fabio Ferreli, MD, IRCCS Humanitas Research Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
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