Prospective Study of Sinonasal and Skull-base Tumours Management (Sinonasal_Tu)

March 6, 2024 updated by: Domen Vozel, MD, PhD, University Medical Centre Ljubljana

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of the disease
Time Frame: twelve months after the treatment completion
Absence of the disease after the treatment has been completed
twelve months after the treatment completion
Overall survival
Time Frame: twelve months after the treatment completion
Survival after the treatment has been completed
twelve months after the treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

University of Ljubljana, Faculty of Medicine

Investigators

  • Study Director: Domen Vozel, MD, PhD, University Medical Centre Ljubljana
  • Study Director: Jure Urbančič, MD, University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 30, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sinonasal tumours

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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