Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Diagnostic performances
研究概览
简要总结
The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Understanding French
- •With symptoms of breast cancer that required a biopsy (microbiopsy or macrobiopsy or surgical biopsy) and pathological examination diagnosing breast cancer
- •First diagnosis of invasive breast cancercarcinoma
- •Affiliated to a social security system
- •Agreeing to participate in the study
排除标准
- •Refusal to participate in the study
- •Not affiliated to the social security system
- •Minor or under legal protection
- •Patient with a history of breast cancer
- •Patient previously treated for breast cancer
- •Patient who has relapsed from breast cancer treatment
- •Non ductal or non lobular invasive breast cancer carcinoma
结局指标
主要结局
Diagnostic performances
时间窗: at inclusion
The diagnostic performance of the automatic marker scoring support tool will be assessed based on the pathologists' gold standard using sensitivity and specificity
次要结局
- Duration of procedure(at inclusion)
- Cognitive savings(at inclusion)
- Diagnostic performances(at inclusion)
- Organizational constraints(at inclusion)
- inter-rater agreement(at inclusion)
- General comfort of use(at inclusion)