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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study
- ClinicalTrials.gov ID
- NCT05693116
- Acronym / sponsor ID
- NV-SCC / 3273
- Keywords
- nasal vestibule, squamous cell carcinoma, rhinectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Vestibule Squamous Cell Carcinoma | – | Procedure: RhinectomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by primary squamous cell carcinoma of the nasal vestibule.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhinectomySurgery will be performed according to extension of the tumour, i.e. local resection limited to the vestibule, partial rhinectomy, total rhinectomy, extended total rhinectomy | Procedure or surgery | Nasal Vestibule Squamous Cell Carcinoma |
Primary outcome
Survival
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Overall Survival
Survival
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Disease Free Survival
Survival
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Disease Specific Survival
16 secondary outcomes
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Factors influencing survival (demographics, tumour-related, surgery-related)
Time frame: From time of enrollment to event (death, recurrence) up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 35490569Ferreli 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.
- Background: PubMed 33006408Lambertoni 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.
- Background: PubMed 34223976Chabrillac 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.
- Individual participant dataSharing planned: No
Related trials for Nasal Vestibule Carcinoma
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Brachytherapy (Interventional Radiotherapy) for Squamous Cell Carcinomas of the Nasal Vestibule: Optimization of Dose and Technique
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Davide Di Santo, MD contact
Fabio Ferreli, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Vestibule Carcinoma and Rhinectomy, run by Istituto Clinico Humanitas at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Pirola, MD (00390282243557, francesca.pirola@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: From time of enrollment to event (death, recurrence) up to 60 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693116, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.