To hear about similar clinical trials, please enter your email below
Trial Title:
Prospective Study of Sinonasal and Skull-base Tumours Management
NCT ID:
NCT05607888
Condition:
Nasal Neoplasm
Nasal Neoplasm Benign
Skull Base Neoplasms
Skull Base Osteomyelitis
Sinonasal Disorder
Sinus Disease
Conditions: Official terms:
Osteomyelitis
Neoplasms
Skull Base Neoplasms
Nose Neoplasms
Paranasal Sinus Diseases
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Centre Ljubljana
Address:
City:
Ljubljana
Zip:
1000
Country:
Slovenia
Status:
Recruiting
Contact:
Last name:
Domen Vozel, MD, PhD
Email:
domen.vozel@kclj.si
Contact backup:
Last name:
Jure Urbančič, MD
Email:
jure.urbancic@kclj.si
Start date:
January 1, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
University Medical Centre Ljubljana
Agency class:
Other
Collaborator:
Agency:
University of Ljubljana, Faculty of Medicine
Agency class:
Other
Source:
University Medical Centre Ljubljana
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05607888
