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NCT Number: NCT05693116

Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule

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.

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Key information

Conditions

Nasal Vestibule Carcinoma Carcinoma Carcinoma, Squamous Cell Nasal Vestibule Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Rhinectomy Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Toulouse, Toulouse, Touluse, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rhinectomy

Procedure

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

Primary outcomes

  1. Survival

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Overall Survival

  2. Survival

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Disease Free Survival

  3. Survival

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Disease Specific Survival

Secondary outcomes

  1. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Gender

  2. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Age

  3. 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

  4. 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

  5. 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)

  6. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    cN stage

  7. 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)

  8. 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)

  9. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Grade

  10. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Dimensions

  11. 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

  12. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Perineural invasion

  13. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Perivascular invasion

  14. 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

  15. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Surgical procedure

  16. Factors influencing survival (demographics, tumour-related, surgery-related)

    Time frame: From time of enrollment to event (death, recurrence) up to 60 months.

    Adjuvant treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Davide Di Santo, MD

CONTACT

Francesca Pirola, MD

CONTACT

[email protected]

00390282243557

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study

Acronym: NV-SCC

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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