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Trial Title:
Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
NCT ID:
NCT05693116
Condition:
Nasal Vestibule Carcinoma
Rhinectomy
Nasal Vestibule
Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Conditions: Keywords:
nasal vestibule
squamous cell carcinoma
rhinectomy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Procedure
Intervention name:
Rhinectomy
Description:
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
Arm group label:
Nasal Vestibule Squamous Cell Carcinoma
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.
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.
Criteria for eligibility:
Study pop:
Patients affected by primary squamous cell carcinoma of the nasal vestibule.
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire de Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Emile Chabrillac
Facility:
Name:
Humanitas Research Hospital
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Ferreli
Facility:
Name:
Cagliari University Hospital
Address:
City:
Cagliari
Zip:
09124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Filippo Carta
Facility:
Name:
IRCCS San Raffaele Hospital
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Galli
Facility:
Name:
Varese University Hospital
Address:
City:
Varese
Zip:
21100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mario Turri-Zanoni
Facility:
Name:
Sheffield Teaching Hospital NHS Foundation Trust
Address:
City:
Sheffield
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sara Sionis
Start date:
December 1, 2022
Completion date:
December 2029
Lead sponsor:
Agency:
Istituto Clinico Humanitas
Agency class:
Other
Source:
Istituto Clinico Humanitas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05693116
