Prospective Study of Sinonasal and Skull-base Tumours Management

Skull Base Neoplasms Clinical Trial

— Sinonasal_Tu  

Official title:

Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607888
• Other study ID #: Sinonasal tumours
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: University Medical Centre Ljubljana
• Contact: Domen Vozel, MD, PhD
• Phone: +38641747865
• Email: domen.vozel[@]kclj.si
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. The main questions it aims to answer are:

• what is the caseload of patients with the included pathology in our centre

• what are the results of management of these cases

• what are the epidemiological characteristics of included patients

• what is the quality of life of included patients.

Description:

Sinonasal tumours and tumours that involve the adjacent skull base are rare entities. However, their management necessitates a special knowledge of ENT areas and specifics of sinonasal anatomy and skull base. Due to the heterogeneity of pathological diagnoses of sinonasal and skull-base tumours, one of the main aims of this study is to provide epidemiological characteristics in our geographical area. Furthermore, to compare with other tertiary referral centres, we will analyse management results, which could improve the management of these diseases. Since the sinonasal area and skull base house several important neuroanatomical structures and senses, we aim to provide an analysis of the patient-reported quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• sinonasal and/or skull-base cancer

• sinonasal disease expanding through the skull-base

• the patient's written informed consent

Exclusion Criteria:

• lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement

Related Conditions & MeSH terms

• Neoplasms
• Nose Neoplasms
• Osteomyelitis
• Paranasal Sinus Diseases
• Sinus Disease
• Skull Base Neoplasms

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of the disease	Absence of the disease after the treatment has been completed	twelve months after the treatment completion
Primary	Overall survival	Survival after the treatment has been completed	twelve months after the treatment completion