Prospective Study of Sinonasal and Skull-base Tumours Management

NCT05607888 | Recruiting

• 1 other identifier: Sinonasal tumours
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Absence of the disease

  Absence of the disease after the treatment has been completed

  twelve months after the treatment completion

• Overall survival

  Survival after the treatment has been completed

  twelve months after the treatment completion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Nose Neoplasms; Skull Base Neoplasms; Paranasal Sinus Diseases

Condition Hierarchy (Ancestors)

Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Bone Diseases; Musculoskeletal Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Domen Vozel, MD, PhD

  University Medical Centre Ljubljana

  STUDY DIRECTOR

• Jure Urbančič, MD

  University Medical Centre Ljubljana

  STUDY DIRECTOR

Central Study Contacts

Domen Vozel, MD, PhD

CONTACT

+38641747865; domen.vozel@kclj.si

Jure Urbančič, MD

CONTACT

jure.urbancic@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Domen Vozel, MD, PhD, principal investigator

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 7, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

SL (1)