Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule (NV-SCC)

January 11, 2023 updated by: Istituto Clinico Humanitas

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Davide Di Santo, MD

Study Locations

  • France
    • Touluse
      • Toulouse, Touluse, France
        • Recruiting
        • Centre Hospitalier Universitaire De Toulouse
        • Contact:
          • Emile Chabrillac
  • Italy
      • Cagliari, Italy, 09124
        • Recruiting
        • Cagliari University Hospital
        • Contact:
          • Filippo Carta
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Hospital
        • Contact:
          • Andrea Galli
      • Varese, Italy, 21100
        • Recruiting
        • Varese University Hospital
        • Contact:
          • Mario Turri-Zanoni
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Recruiting
        • Humanitas Research Hospital
        • Contact:
          • Fabio Ferreli
  • United Kingdom
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield teaching hospital NHS foundation trust
        • Contact:
          • Sara Sionis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by primary squamous cell carcinoma of the nasal vestibule.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: From time of enrollment to event (death, recurrence) up to 60 months.
Overall Survival
From time of enrollment to event (death, recurrence) up to 60 months.
Survival
Time Frame: From time of enrollment to event (death, recurrence) up to 60 months.
Disease Free Survival
From time of enrollment to event (death, recurrence) up to 60 months.
Survival
Time Frame: From time of enrollment to event (death, recurrence) up to 60 months.
Disease Specific Survival
From time of enrollment to event (death, recurrence) up to 60 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors influencing survival (demographics, tumour-related, surgery-related)
Time Frame: From time of enrollment to event (death, recurrence) up to 60 months.
Gender
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.
Age
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.
Site of origin of the tumour
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.
Subsites involved by the tumour
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.
cT stage (according to TNM nasal cavities, Wang classification, TNM skin)
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.
cN stage
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.
pT stage (according to TNM nasal cavities, Wang classification, TNM skin)
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.
pN stage (according to TNM nasal cavities, Wang classification, TNM skin)
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.
Grade
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.
Dimensions
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.
Depth of infiltration
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.
Perineural invasion
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.
Perivascular invasion
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.
Surgical margin status
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.
Surgical procedure
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.
Adjuvant treatment
From time of enrollment to event (death, recurrence) up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Fabio Ferreli, MD, Irccs Humanitas Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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