Prospective Study of Sinonasal and Skull-base Tumours Management

Overview

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.

Full Title of Study: “Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2027

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Centre Ljubljana
  • Collaborator
    • University of Ljubljana, Faculty of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Domen Vozel, MD, PhD, Domen Vozel, MD, PhD, principal investigator – University Medical Centre Ljubljana
  • Overall Official(s)
    • Domen Vozel, MD, PhD, Study Director, University Medical Centre Ljubljana
    • Jure Urbančič, MD, Study Director, University Medical Centre Ljubljana
  • Overall Contact(s)
    • Domen Vozel, MD, PhD, +38641747865, domen.vozel@kclj.si

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.