跳至主要内容
临床试验/NCT05607888
NCT05607888招募中不适用

Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Overall survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • sinonasal and/or skull-base cancer
  • sinonasal disease expanding through the skull-base
  • the patient's written informed consent

排除标准

  • lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement

结局指标

主要结局

Overall survival

时间窗: twelve months after the treatment completion

Survival after the treatment has been completed

Absence of the disease

时间窗: twelve months after the treatment completion

Absence of the disease after the treatment has been completed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Domen Vozel, MD, PhD

Domen Vozel, MD, PhD, principal investigator

University Medical Centre Ljubljana

研究点 (1)

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