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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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