Prospective Study of Sinonasal and Skull-base Tumours Management

NCT ID: NCT05607888

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Domen Vozel, MD, PhD

Domen Vozel, MD, PhD, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Domen Vozel, MD, PhD

Role: STUDY_DIRECTOR

University Medical Centre Ljubljana

Jure Urbančič, MD

Role: STUDY_DIRECTOR

University Medical Centre Ljubljana

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Domen Vozel, MD, PhD

Role: CONTACT

domen.vozel@kclj.si

+38641747865

Jure Urbančič, MD

Role: CONTACT

jure.urbancic@kclj.si

Facility Contacts

Domen Vozel, MD, PhD

Role: primary

domen.vozel@kclj.si

Jure Urbančič, MD

Role: backup

jure.urbancic@kclj.si

Other Identifiers

Sinonasal tumours

Identifier Type: -

Identifier Source: org_study_id