Blood Test for Breast Cancer Associated Auto Antibodies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
Intend of use: A blood test for Cancer Associated Auto Antibodies (CAAA) aimed for better diagnostic management of suspected subjects with breast pathology
Study Description: Blood is collected form patients and serum is tested for the presence of CAAA on experimental test kit.
Objectives: To assess the effectiveness of the CAAA test.
Patient Population: The study population will include any women with suspected breast mass detected by any conventional method, scheduled for biopsy, which will result with a pathological verification of the suspected mass.
Target Population: The target population will be any women with suspected breast mass detected by any conventional method, that today, is scheduled for biopsy.
Structure: Subjects that will be enrolled for the study will be checked for the presence of CAAAb, and the results of the CAAAb test will be compared to the pathology submitted by the physicians in the participating centers.
Sample Size: Total of 1000 samples, of which 620 samples will ensure at least 124 true positive breast cancer subjects verified by biopsy, and 124 true negative breast cancer subjects verified by biopsy. Additional 400 samples will be used for calibrations and training sets.(Multi center study, statistical rationale provided below).
Primary Effectiveness Variables: The effectiveness of the test will be defined by the specificity of the test conditionally that the sensitivity is not lower than a pre-defined level of 95%.
Endpoint: The endpoint of this study is to show that the effectiveness is higher than 50%.
Study Sponsor: Eventus Diagnostics Ltd.
Clinical Monitor: For each site a dedicated CRO will be appointed to monitor the clinical trials. All data will be stored in a protected internet-based database, and any changes of the data will be traced and recorded.
详细描述
General Information:
Since the mutations of a normal cell that lead to a malignancy, involves changes in the structure and function of the cells, it could be assumed that the immune system has recognized some of these changes as antigenic determinates that should be responded against. For many years, investigators tried to distinguish between cancer patients and healthy population by the difference in specific autoantibodies level. In the healthy population, a baseline of the amount of autoantibodies was determined, and the patient population had to have a statistically significant higher level of autoantibodies. Many examples of this method can be found in the scientific literature [example references - Naora et.al. (2001); mintz et. Al. (2003); Korneeva et. Al (2000)]. The presence of autoantibodies in all population in different levels made it very difficult to find these specifically discriminating antibodies. To date, no specific autoantibody is distinguishing solely between healthy and cancer patients (as opposed to autoimmune diseases, where specific autoantibodies can be found in very high levels in patients only).
Our work assumes that specific Autoantibodies expression level should be altered in cancer, and thus these differences can indicate the presence / absence of cancer.
In this experiment protocol, we are checking for differences in expression levels of specific autoantibodies of suspected breast pathology.
Future CAAA Test Intend of use - Identification of specific breast CAAAs, could provide the clinician with additional immunological and antigenic information regarding the patient's condition or medical status.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects 18 years or over.
- •Subjects suspected of breast cancer. The clinical suspicion will include one of the following: positive mammography, ultrasound (US), magnetic resonance imaging (MRI), suspected physical exam. Final analysis will be done in relation to pathology only.
- •Subjects scheduled biopsy/surgery
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