Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- clinical evolution, treatment and prognosis
研究概览
简要总结
Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma.
详细描述
Basal cell carcinoma (BCC) is an epithelial tumor characterized by the malignant proliferation of keratinocytes in the basal layer of the epidermis. It is part, along with squamous cell carcinoma (SCC),non-melanoma skin cancer (NMSC) and accounts for 80% of all skin cancers and the most common skin cancer in the United States and Europe. Estimates of BCC incidence, however, are inaccurate since in most countries there is no cancer register collecting data on BCC incidence and many patients are treated on a territorial outpatient basis, making data collection and epidemiological analysis complex. In recent decades, there has been an increasing trend in patients with BCC, as well as a reduction in the average age of onset, with a consequent drastic increase in the social and economic cost of healthcare facilities. From these considerations, arises the need to investigate and characterize the profile of patients with advanced BCC, the clinical characteristics and the course of such neoplasm, and the choice of therapeutic options available.
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
- •Male and female patients aged ≥ 18 years
- •Patients diagnosed with advanced basal cell carcinoma of the skin, i.e. tumours included in at least one of the following categories: locally advanced carcinoma (not radically treatable by surgery and/or radiotherapy), carcinoma with lymph node and/or distant metastatic localisation
- •patients who have had at least one access (first visit or follow-up visit) at the dermatology or oncology outpatient clinic of the centres involved
- •Patients diagnosed with advanced BCC who have accessed the centre from 1 January 2016 until the date of activation of the centre will be included in the retrospective cohort;
- •Patients diagnosed with advanced BCC who have accessed the centre from the date of activation
- •Signature of informed consent
排除标准
- •Patients incapable of giving informed consent
结局指标
主要结局
clinical evolution, treatment and prognosis
时间窗: from baseline through study completion, an average of 3 years
clinical profile of patient, the phenotypic and behavioural characteristic and the clinical course from baseline to follow-up.
次要结局
未报告次要终点