Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Real-world demographics in routine clinical practice
研究概览
简要总结
This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. The overall objective is to describe characteristics, management and treatment outcomes for patients presenting with advanced NMSC (cSCC/BCC) or HR-cSCC in routine clinical practice, independent of treatments used across different European regions.
详细描述
Skin cancer is one of the most common cancers worldwide, and the most frequent cancer in the white population. Incidence rates of NMSC are increasing, partly attributable to more outdoor leisure activities and aging population. Among NMSC, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) are the most predominant histologic subtypes. Real-world data especially those systematically recorded in registries are limited. With limited resources, many cancer databases do not register all primary NMSCs. For advanced patients with NMSC, the EUMelaReg consortium (EMR) introduces a registry specific for NMSC across Europe (EMR-NMSC) which brings together national registries and operates as a higher-level registry. The aim of this registry is to collect real-world data of the available diagnosis and treatment pattern of advanced NMSC patients at a European level. Data of the EMR NMSC-Registry can be used for specific pre-defined analyses regarding drugs, availability and affordability of various treatments for different patient populations, data on health-related resource utilization, outcome data, and risk factors.
Quality management Study participating sites are responsible for recording and verifying the accuracy of subject data.
A data management plan (DMP) will be in place which describes the life cycle of the study data from the collection to archiving, including all measures to ensure that the data remain available, usable and comprehensible. It includes rules and regulations for e.g. data validation, data processing, medical coding, quality review procedures and archiving of study documentation. National and international data protection laws as well as regulations on registries will be followed.
Data validation Detailed information on checks for completeness, accuracy, plausibility and validity are given in the data validation plan (DVP). The computerized handling of the data by the service provider may generate requests to which the participating site needs to respond by confirming or modifying the data questioned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients aged ≥18 years at index date
- •Patients documented in the European NMSC-registry fulfilling EMR quality standard
- •Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting OR Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2) OR Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3)
排除标准
- •Patients receiving treatment within a clinical trial.
结局指标
主要结局
Real-world demographics in routine clinical practice
时间窗: min. 2 years up to max 5 years of observation
To capture real-world demographics in routine clinical practice, independent of treatment used across different European regions in patients with advanced cSCC, advanced BCC, and completely resected HR-cSCC.
次要结局
- Treatment patterns(min. 2 years up to max 5 years of observation)
- Tumor characteristics(min. 2 years up to max 5 years of observation)
- Time to next treatment (TTNT) - for advanced cSCC, advanced BCC only(min. 2 years up to max 5 years of observation)
- Time to recurrence (TTR)(min. 2 years up to max 5 years of observation)
- Disease Free Survival (DFS)(min. 2 years up to max 5 years of observation)
- Time to progression (TTP) - for advanced BCC only(min. 2 years up to max 5 years of observation)
- Freedom from locoregional recurrence (FFLRR)(min. 2 years up to max 5 years of observation)
- Overall survival(min. 2 years up to max 5 years of observation)
- Adverse drug reactions(min. 2 years up to max 5 years of observation)
- Time to treatment discontinuation (TTD) - for advanced cSCC, advanced BCC only(min. 2 years up to max 5 years of observation)
- Progression free survival (PFS) - for advanced cSCC, advanced BCC only(min. 2 years up to max 5 years of observation)
- Treatment discontinuation(min. 2 years up to max 5 years of observation)
- Time to progression (TTP) - for advanced cSCC(min. 2 years up to max 5 years of observation)
- Overall response rate (ORR) - for advanced cSCC, advanced BCC only(min. 2 years up to max 5 years of observation)
- Freedom from distant recurrence (FFDR)(min. 2 years up to max 5 years of observation)