Blood Test for Ovarian Cancer Associated Auto Antibodies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of participants in each of the clinicaly defined groups (OC, suspected and control).
研究概览
简要总结
Intend of use: A blood test for Cancer Associated Antibodies (CAAA) is an aid in initial diagnosis of ovarian cancer in women with suspected ovarian pathology as detected by primary diagnostic techniques.
Test Description: Blood is collected from patients and serum/plasma is tested for the presence of CAAA on experimental test kit.
Objectives: To assess the effectiveness of the CAAA test.
Target Population:
The study population will include women that have been diagnosed with suspected ovarian cancer (OC), verified by pathology/cytology as patients, women with suspected ovarian cancer but verified by pathology/cytology as non-cancers and a control set of blood samples will be collected from age matched women with no history of cancer.
Structure: Women 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 for the patient population and to the clinical history for the control population.
Sample Size: The investigators will collect at least 50 patients verified by pathology/cytology and for each patient at least two aged matched healthy controls and two aged matched suspected but verified as non-cancers. Total amount at least 250 samples.
(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%.
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
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. 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 changes can indicate the presence / absence of cancer.
In this experiment protocol, we are checking for changes in expression levels of specific autoantibodies of women with ovarian pathology compared to women without cancer.
The CAAA test is comprised of a blood collection and processing step followed by detection of specific auto antibodies with an ELISA based assay and a mathematical processing, with a subsequent classification of the results as "positive" or "negative" for ovarian cancer.
The study population includes those women that are scheduled for a pathological or cytological confirmation either by a surgical procedure (laparoscopy/laparotomy) or any kind of biopsy or cytology, prior to any anti-cancer treatment and aged matched controls. The clinical suspicion includes one of the following: Pelvic mass/cyst (by pelvic examination and/or imaging techniques), and/or high CA-125 levels, and/or ascites, and/or due to incidental finding of distant metastasis. Final verification ("true positive" or "true negative") will be done in relation to pathology/cytology results only or for healthy women in relation to clinical history.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 years or over.
- •Patients suspected of ovarian pathology. The clinical suspicion will include one of the following: Pelvic mass/cyst (by pelvic examination and/or other imaging techniques), and/or high CA-125 levels, and/or ascites, and/or due to incidental finding of distant metastasis. Final analysis will be done in relation to pathology/cytology results only.
- •Patients scheduled laparotomy/laparoscopy/surgery, ideally before any of the above.
排除标准
- •Less than 18 years of age
- •Hematological malignancies
- •Autoimmune disorders diagnosed patients.
- •Previous or current tumors
- •Patients under active chemotherapy treatment
结局指标
主要结局
Number of participants in each of the clinicaly defined groups (OC, suspected and control).
时间窗: 5 years
次要结局
未报告次要终点