Automated Method for Breast Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 4
- 主要终点
- Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion
研究概览
简要总结
Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient must be female
- •Patient must be 18 years of age or older
- •Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion
排除标准
- •Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).
结局指标
主要结局
Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion
时间窗: up to 2 years
Number of participants in whom DNA methylation profile of 10 genes in the Cancer Detection cartridge correlates with diagnosis based on the gold standard of histopathology of the core biopsy or resected sample.
Correlation of Diagnostic Cartridge With Cytopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)
时间窗: up to 2 years
Number of participants in whom DNA methylation profile of 10 genes as determined in the Cancer Detection cartridge correlates with FNA cytology
次要结局
- Correlation of Diagnostic Cartridge With Known Lab Assay(up to 2 years)
- Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections(up to 2 years)
- Correlation of Known Lab Assay for FNA Versus the Core Biopsy(up to 2 years)