Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service
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
- 否
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
Domen Vozel, MD, PhD
Domen Vozel, MD, PhD, principal investigator
University Medical Centre Ljubljana
