Nasal NeoplasmSinonasal_TuNCT05607888
Prospective Study of Sinonasal and Skull-base Tumours Management
An observational study of Nasal Neoplasm and Nasal Neoplasm Benign, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasal Neoplasm, Nasal Neoplasm Benign, Skull Base Neoplasms
- How many people
- 120 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2022to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- sinonasal and/or skull-base cancer
- sinonasal disease expanding through the skull-base
- the patient's written informed consent
Who cannot join
- lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jure Urbančič, MD contact
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, Ljubljana, 1000
Domen Vozel, MD, PhD, domen.vozel@kclj.si
Jure Urbančič, MD, jure.urbancic@kclj.si
About this study
Official title: Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service
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.
- Conditions
- Nasal Neoplasm, Nasal Neoplasm Benign, Skull Base Neoplasms, Skull Base Osteomyelitis, Sinonasal Disorder, Sinus Disease
- Medical subject headings
- Nose Neoplasms, Skull Base Neoplasms, Paranasal Sinus Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of the disease
Absence of the disease after the treatment has been completed
Measured: twelve months after the treatment completion
Overall survival
Survival after the treatment has been completed
Measured: twelve months after the treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal NeoplasmStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Responsible party
- Principal investigator, Domen Vozel, MD, PhD, University Medical Centre Ljubljana
- Investigators
- Domen Vozel, MD, PhD, Study director, University Medical Centre LjubljanaJure Urbančič, MD, Study director, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607888
- Sponsor's protocol ID
- Sinonasal tumours
- Acronym
- Sinonasal_Tu
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service
- ClinicalTrials.gov ID
- NCT05607888
- Acronym / sponsor ID
- Sinonasal_Tu / Sinonasal tumours
- Conditions
- Nasal Neoplasm, Nasal Neoplasm Benign, Skull Base Neoplasms, Skull Base Osteomyelitis, Sinonasal Disorder, Sinus Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- sinonasal and/or skull-base cancer
- sinonasal disease expanding through the skull-base
- the patient's written informed consent
Key exclusion criteria (1 listed)
- lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absence of the disease
Time frame: twelve months after the treatment completion
Absence of the disease after the treatment has been completed
Overall survival
Time frame: twelve months after the treatment completion
Survival after the treatment has been completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 41560283Vozel 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.
Related trials for Nasal Neoplasm
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jure Urbančič, MD contact
Domen Vozel, MD, PhD study director
University Medical Centre Ljubljana
Jure Urbančič, MD study director
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Neoplasm and Nasal Neoplasm Benign, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domen Vozel, MD, PhD (+38641747865, domen.vozel@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of the disease (time frame: twelve months after the treatment completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05607888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.