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

Squamous Cell Carcinoma Clinical Trial

— NV-SCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693116
• Other study ID #: 3273
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 2029

Study information

• Verified date: January 2023
• Source: Istituto Clinico Humanitas
• Contact: Francesca Pirola, MD
• Phone: 00390282243557
• Email: francesca.pirola[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2029
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Toulouse	Toulouse	Touluse
Italy	Cagliari University Hospital	Cagliari
Italy	IRCCS San Raffaele Hospital	Milan
Italy	Humanitas Research Hospital	Rozzano	Milan
Italy	Varese University Hospital	Varese
United Kingdom	Sheffield Teaching Hospital NHS Foundation Trust	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Countries where clinical trial is conducted

France,  Italy,  United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Overall Survival	From time of enrollment to event (death, recurrence) up to 60 months.
Primary	Survival	Disease Free Survival	From time of enrollment to event (death, recurrence) up to 60 months.
Primary	Survival	Disease Specific Survival	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Gender	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Age	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	cN stage	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	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.
Secondary	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.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Grade	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Dimensions	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Depth of infiltration	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Perineural invasion	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Perivascular invasion	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Surgical margin status	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Surgical procedure	From time of enrollment to event (death, recurrence) up to 60 months.
Secondary	Factors influencing survival (demographics, tumour-related, surgery-related)	Adjuvant treatment	From time of enrollment to event (death, recurrence) up to 60 months.