Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule: a Multi-centre Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Survival
研究概览
简要总结
The goal of this observational study is to learn about survival and prognostic factors in patients who underwent surgical treatment for primary squamous cell carcinoma of the nasal vestibule. The main questions it aims to answer are:
- what is the prognosis of patients affected by squamous cell carcinoma of the nasal vestibule?
- are there any specific factors that could influence prognosis?
- is it possible to elaborate a new staging system, able to overcome the limitations of the currently used ones? Data about patients, tumour and type of surgery performed will be collected. Participants will be followed-up for a minimum 6 months period after surgery.
详细描述
This study will address the survival of patients with squamous cell carcinoma of the nasal vestibule (NV-SCC), and it will analyze factors influencing it.
In particular, apart from demographic features of the patient, data regarding the origin of the tumour and its extension will be collected and the lesion will be restaged according the the three classification systems used at present (Wang's classification, AJCC for nasal cavity cancers, AJCC for non-melanomatous skin cancer of head and neck region), given the current controversy regarding the best staging system. Furthermore data related to the surgery and the final histology will be collected.
All collected data will be analyzed in order to investigate any possible factor related to overall survival, disease specific survival and disease free survival.
Patients will be followed for a minimum of 6 months up to 5 years after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of squamous cell carcinoma of the nasal vestibule
- •underwent upfront surgical treatment with curative intent
- •availability of clinical and radiological data for cT reassessment
- •availability of histological samples for pT reassessment
- •follow-up of at least 6 months after surgery.
排除标准
- •patients initially referred for disease persistence or recurrence
- •patients affected by tumour involving the nasal vestibule but originating from other sites (eg. nasal cavities, skin of the nasal pyramid or upper lip)
结局指标
主要结局
Survival
时间窗: From time of enrollment to event (death, recurrence) up to 60 months.
Disease Specific Survival
次要结局
- Factors influencing survival (demographics, tumour-related, surgery-related)(From time of enrollment to event (death, recurrence) up to 60 months.)