NCT02666261已完成不适用
A Non-interventional Study on the Epidemiology and Testing of HER2 in Breast Cancer in Germany
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,000
- 试验地点
- 64
- 主要终点
- Number of HER2 Positive Samples
研究概览
简要总结
This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Samples derived from men and women of age greater than or equal to (>/=) 18 years
- •Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or
- •(Histo-)Pathological work-up of the tumor sample as at or after start of this study
- •Available information on the year of birth of the participant
- •No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up.
排除标准
- •Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up.
- •Samples derived prior to the start of this study.
结局指标
主要结局
Number of HER2 Positive Samples
时间窗: 1 day (this is a single time point study)
次要结局
- Number of HER2 Positive Samples by Applied Method of Tissue Fixation(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Round Robin Tests(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Carcinoma Subtype (No Special Type\Ductal, Lobular, Other Special Type)(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate)(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Sample Source (Primary Tumor, Local Lymph Nodes, Metastasis)(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Testing Platform(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Automation of Testing(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Tumor Grading(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Participant Age(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Tumor-Node-Metastasis (TNM) Classification(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Scoring Algorithm(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Antibody Clone Antibody or Test Certification(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Institute's Certification(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Institute's Accreditation(1 day (this is a single time point study))
- Number of HER2 Positive Samples by Hormone Receptor Status(1 day (this is a single time point study))
研究者
研究点 (64)
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