Nasal Vestibule CarcinomaNV-SCCNCT05693116
Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
An observational study of Nasal Vestibule Carcinoma and Rhinectomy, run by Istituto Clinico Humanitas at 6 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Vestibule Carcinoma, Rhinectomy, Nasal Vestibule
- What is being tested?
- Rhinectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Dec 2022to Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by primary squamous cell carcinoma of the nasal vestibule.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Davide Di Santo, MD contact
6 sites in 3 countries
Italy4 sites, 4 recruiting
- Recruiting
Cagliari University Hospital
Cagliari, 09124
Filippo Carta
- Recruiting
IRCCS San Raffaele Hospital
Milan, 20132
Andrea Galli
- Recruiting
Humanitas Research Hospital
Rozzano, Milan, 20089
Fabio Ferreli
- Recruiting
Varese University Hospital
Varese, 21100
Mario Turri-Zanoni
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse, Touluse
Emile Chabrillac
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield
Sara Sionis
About this study
Official title: Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study
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.
Read the 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.
- Being tested
- Rhinectomy
- Keywords
- nasal vestibule, squamous cell carcinoma, rhinectomy
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Rhinectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Overall Survival
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Survival
Disease Free Survival
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Survival
Disease Specific Survival
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Secondary outcomes (16)
Factors influencing survival (demographics, tumour-related, surgery-related)
Gender
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Age
Measured: 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
Measured: 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
Measured: 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)
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
cN stage
Measured: 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)
Measured: 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)
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Grade
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Dimensions
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Depth of infiltration
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Perineural invasion
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Perivascular invasion
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Surgical margin status
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Surgical procedure
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Adjuvant treatment
Measured: From time of enrollment to event (death, recurrence) up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nasal Vestibule CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Ferreli, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693116
- Sponsor's protocol ID
- 3273
- Acronym
- NV-SCC
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35490569Lambertoni 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.
PubMed 33006408Chabrillac 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.
PubMed 34223976