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NCT Number: NCT05607888

Prospective Study of Sinonasal and Skull-base Tumours Management

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.

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Key information

Conditions

Nasal Neoplasm Bone Diseases Bone Neoplasms Head and Neck Neoplasms Musculoskeletal Diseases Nasal Neoplasm Benign Neoplasms Neoplasms by Site Nose Diseases Nose Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sinonasal Disorder Sinus Disease Skull Base Neoplasms Skull Base Osteomyelitis Skull Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Domen Vozel, MD, PhD

CONTACT

[email protected]

Jure Urbančič, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Absence of the disease

    Time frame: twelve months after the treatment completion

    Absence of the disease after the treatment has been completed

  2. Overall survival

    Time frame: twelve months after the treatment completion

    Survival after the treatment has been completed

Study contacts

Contact information is provided by the study sponsor or research team.

Domen Vozel, MD, PhD

CONTACT

[email protected]

+38641747865

Jure Urbančič, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana, Faculty of Medicine

Registry information

Official study title

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

Acronym: Sinonasal_Tu

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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