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Recruiting NCT05607888

Prospective Study of Sinonasal and Skull-base Tumours Management

Observational Nasal Neoplasm Nasal Neoplasm Benign Skull Base Neoplasms Skull Base Osteomyelitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Nasal Neoplasm, Nasal Neoplasm Benign, Skull Base Neoplasms, Skull Base Osteomyelitis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Absence of the disease [Time frame: twelve months after the treatment completion]
  • Overall survival [Time frame: twelve months after the treatment completion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Slovenia · 1 center
  • University Medical Centre Ljubljana — Ljubljana

Publications

  • Vozel D, Urbancic J, Battelino S, Urbancic NB, Steiner N, Felbabic T, Bosnjak R. Quality of life in Slovenian patients with skull base tumours: cross-cultural adaptation and validation of a Slovenian skull base inventory. Radiol Oncol. 2026 Jan 21;60(1):106-113. doi: 10.2478/raon-2026-0007. eCollection 2026 Mar 1. PMID 41560283

Identifiers

NCT: NCT05607888 · Sinonasal tumours

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗