Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patients affected by primary squamous cell carcinoma of the nasal vestibule.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Rhinectomy
Procedure/SurgerySurgery will be performed according to extension of the tumour, i.e. local resection limited to the vestibule, partial rhinectomy, total rhinectomy, extended total rhinectomy
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Nasal Vestibule Squamous Cell Carcinoma1 intervention
Trial outcomes
Primary outcomes
1
Survival
Overall Survival
Time frame
From time of enrollment to event (death, recurrence) up to 60 months.2
Survival
Disease Free Survival
Time frame
From time of enrollment to event (death, recurrence) up to 60 months.3
Survival
Disease Specific Survival
Time frame
From time of enrollment to event (death, recurrence) up to 60 months.Secondary outcomes
1
Factors influencing survival (demographics, tumour-related, surgery-related)
Gender
Time frame
From time of enrollment to event (death, recurrence) up to 60 months.2
Factors influencing survival (demographics, tumour-related, surgery-related)
Age
Time frame
From time of enrollment to event (death, recurrence) up to 60 months.3
Factors influencing survival (demographics, tumour-related, surgery-related)
Site of origin of the tumour
Time frame
From time of enrollment to event (death, recurrence) up to 60 months.4
Factors influencing survival (demographics, tumour-related, surgery-related)
Subsites involved by the tumour
Time frame
From time of enrollment to event (death, recurrence) up to 60 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov