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

Sponsor: Istituto Clinico Humanitas

NCT ID: NCT05693116

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Rhinectomy (procedure)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Rhinectomy — procedure: Surgery will be performed according to extension of the tumour, i.e.
Patient visit burden
Not specified by the sponsor

In plain English

This study looked at people with squamous cell carcinoma (a type of cancer) of the nasal vestibule, which is the area just inside the nostril. Researchers reviewed survival rates and factors that may affect outcomes in patients who had surgery to try to cure the disease. It was carried out by Istituto Clinico Humanitas.

Who can take part

  • Diagnosed with squamous cell carcinoma of the nasal vestibule
  • Had surgery as the first treatment, aiming to cure the cancer
  • Clinical and scan data available to re-check the tumour stage
  • Tissue samples available to re-check the tumour stage
  • Follow-up of at least 6 months after surgery

Who may not be able to

  • Patients first referred because the disease had persisted or come back
  • Tumours involving the nasal vestibule but starting elsewhere (for example, the nasal cavities, the skin of the nose, or the upper lip)

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team (the study required at least 6 months of follow-up after surgery).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
300
Started
2022-12-01
Last checked
2023-01

Plain English Summary

What is this study?

  • • Testing a new treatment for nasal vestibule carcinoma
  • • Clinical study - 300 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with nasal vestibule carcinoma

Where?

  • • Sheffield - Sheffield Teaching Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Nasal Vestibule CarcinomaRhinectomyNasal VestibuleSquamous Cell Carcinoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 take part

  • ✗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...
See the full criteria
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)

Where Is This Study? (1 UK site)

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Francesca Pirola, MD

Sponsor contact

CONTACT

00390282243557 francesca.pirola@humanitas.it

Davide Di Santo, MD

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2023-01