Prospective Study of Sinonasal and Skull-base Tumours Management

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05607888

Acronym

Sinonasal_Tu

Enrollment

120

Registered

2022-11-07

Start date

2022-01-01

Completion date

2027-12-31

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Neoplasm, Nasal Neoplasm Benign, Sinonasal Disorder, Sinus Disease, Skull Base Neoplasms, Skull Base Osteomyelitis

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Slovenia

Contacts

CONTACTDomen Vozel, MD, PhD

domen.vozel@kclj.si+38641747865

CONTACTJure Urbančič, MD

jure.urbancic@kclj.si

STUDY_DIRECTORDomen Vozel, MD, PhD

University Medical Centre Ljubljana

STUDY_DIRECTORJure Urbančič, MD