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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Survival [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Survival [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Survival [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]

Вторичные конечные точки (12)

• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]
• Factors influencing survival (demographics, tumour-related, surgery-related) [Срок оценки: From time of enrollment to event (death, recurrence) up to 60 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 4 центра

• Humanitas Research Hospital — Rozzano
• Cagliari University Hospital — Cagliari
• IRCCS San Raffaele Hospital — Milan
• Varese University Hospital — Varese

Франция · 1 центр

• Centre Hospitalier Universitaire de Toulouse — Toulouse

Великобритания · 1 центр

• Sheffield Teaching Hospital NHS Foundation Trust — Sheffield

Публикации

• 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

Идентификаторы

NCT: NCT05693116 · 3273

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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