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RecruitingNCT05607888Sinonasal_TuUpdated Apr 29, 2026

Prospective Study of Sinonasal and Skull-base Tumours Management

An observational study in Nasal Neoplasm, Nasal Neoplasm Benign and Skull Base Neoplasms, sponsored by University Medical Centre Ljubljana. Recruiting at 1 site in Slovenia. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University Medical Centre Ljubljana · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Nasal Neoplasm
  • Nasal Neoplasm Benign
  • Skull Base Neoplasms
  • Skull Base Osteomyelitis
  • Sinonasal Disorder
  • Sinus Disease
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will be recruited from patients referred to the tertiary otorhinolaryngology referral centre. The referral applies to the in-hospital or outpatient setting.

Inclusion criteria

  • sinonasal and/or skull-base cancer
  • sinonasal disease expanding through the skull-base
  • the patient's written informed consent

Exclusion criteria

Exclusion Criteria:

  • lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Absence of the disease

    Absence of the disease after the treatment has been completed

    Time frame: twelve months after the treatment completion

  2. Overall survival

    Survival after the treatment has been completed

    Time frame: twelve months after the treatment completion

06

Study locations

1 of 1 sites recruiting
07

References and documents

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. PubMed 41560283 ↗
08

Registry details

Key details

Study ID
NCT05607888
Lead sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana, Faculty of Medicine
Responsible party
Domen Vozel, MD, PhD (Domen Vozel, MD, PhD, principal investigator, University Medical Centre Ljubljana) — Principal investigator
First posted
Nov 7, 2022
Start date
Jan 1, 2022
Primary completion
Jan 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 29, 2026

Study contacts

Domen Vozel, MD, PhD
Contact
domen.vozel@kclj.si
+38641747865
Jure Urbančič, MD
Contact
jure.urbancic@kclj.si
Domen Vozel, MD, PhD
study director · University Medical Centre Ljubljana
Jure Urbančič, MD
study director · University Medical Centre Ljubljana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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