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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhinectomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall Survival | From time of enrollment to event (death, recurrence) up to 60 months. |
| Survival | Disease Free Survival | From time of enrollment to event (death, recurrence) up to 60 months. |
| Survival | Disease Specific Survival | From time of enrollment to event (death, recurrence) up to 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Factors influencing survival (demographics, tumour-related, surgery-related) | Gender | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients affected by primary squamous cell carcinoma of the nasal vestibule.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Pirola, MD | Contact | 00390282243557 | francesca.pirola@humanitas.it | |
| Davide Di Santo, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Fabio Ferreli, MD | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Toulouse | Recruiting | Toulouse | Touluse | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35490569 | Background | 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. | |
| 33006408 | Background | 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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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Age
| From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Site of origin of the tumour | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Subsites involved by the tumour | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | cT stage (according to TNM nasal cavities, Wang classification, TNM skin) | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | cN stage | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | pT stage (according to TNM nasal cavities, Wang classification, TNM skin) | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | pN stage (according to TNM nasal cavities, Wang classification, TNM skin) | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Grade | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Dimensions | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Depth of infiltration | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Perineural invasion | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Perivascular invasion | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Surgical margin status | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Surgical procedure | From time of enrollment to event (death, recurrence) up to 60 months. |
| Factors influencing survival (demographics, tumour-related, surgery-related) | Adjuvant treatment | From time of enrollment to event (death, recurrence) up to 60 months. |
| Humanitas Research Hospital | Recruiting | Rozzano | Milan | 20089 | Italy |
|
| Cagliari University Hospital | Recruiting | Cagliari | 09124 | Italy |
|
| IRCCS San Raffaele Hospital | Recruiting | Milan | 20132 | Italy |
|
| Varese University Hospital | Recruiting | Varese | 21100 | Italy |
|
| Sheffield Teaching Hospital NHS Foundation Trust | Recruiting | Sheffield | United Kingdom |
|
| 34223976 | Background | 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. |
| D018307 |
| Neoplasms, Squamous Cell |