Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,425
- 试验地点
- 1
- 主要终点
- Number of participants in each of the clinicaly defined groups (0,1 and 2).
研究概览
简要总结
Octava has two versions, each with a different intend of use.
OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized clinical laboratories. The product is used for two following indications:
- Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed mammography and were determined negative for breast cancer. Being moderately sensitive (>55% sensitivity) the test is able to detect 55% of mammography false negatives. In addition, being highly specific (>95% specificity) it supplies additional evidence for true mammography negative result which will reduce examinees anxiety of being misdiagnosed as a result of high false negative mammography rate (10-30%)
- Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed biopsy after positive mammography and the biopsy result was negative. Being moderately sensitive (>55% sensitivity) the test is able to detect 55% of biopsy false negatives. In addition being highly specific (>95% specificity) it supplies an additional evidence for true biopsy negative result which reduces examinees anxiety of being misdiagnosed.
OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx authorized laboratories. Intend of use of OctavBlue is the following:
• OctavBlue is indicated for women above 18 years old, who performed mammography and received doubtful results. Being highly sensitive (>95% sensitivity) the test can help to reveal 95% of positive cases; and being moderately specific (>55% specificity) - about half of negative cases. The test is not intended to be used as a standalone diagnostic technique but to supply additional information to a physician and help deciding about the further course of diagnosis.
详细描述
The primary objectives - To improve the specifications of the OctavaPink test and the OctavaBlue test. The current specifications being
- For the OctavaPink - 95% specificity and 50% sensitivity.
- For the OctavaBlue - 50% specificity and 95% sensitivity.
The study will be considered as successful in any of the below options -
- If the new antigens incorporated in the OctavaPink chip will maintain specificity of at least 95% and increase the sensitivity to at least 85%.
- If the new antigens incorporated in the OctavaBlue chip will maintain sensitivity of at least 95% and increase the specificity to at least 85%.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Female subjects 18 years or over.
- •Subjects following a mammography test.
- •Subject with pathological evaluation after mammography with BIRADS 3-4-5-6.
排除标准
- •Female Subjects less than 18 years of age
- •Previous or concurrent malignancies
- •Autoimmune disorders diagnosed subjects
- •Hematological malignancies
- •Subjects under active chemotherapy treatment or chemotherapy in the past 6 months
- •Steroid treatment in the past 3 months
- •Subject undergoing immunosuppressive treatments
- •Subject with verified breast cancer other than invasive ductal or invasive lobular as verified by biopsy/cytology
结局指标
主要结局
Number of participants in each of the clinicaly defined groups (0,1 and 2).
时间窗: 3 years
次要结局
未报告次要终点