Study to Assess the Effectiveness of the CAAb Test With Ovarian Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 5
研究概览
简要总结
Blood is collected from patients and cultured in a CimTube (a test tube with stimulation media) for several days. Following the culture step, the supernatant fluid is tested for the presence of CAAb on experimental test kits.
Null Hypothesis: There is no relationship between the presence or absence of ovarian cancer (OC) and the CAAb i.e. d=0.
Alternative Hypothesis: The expectation of the CAAb in the cancer population differs from that of the control population, i.e. m1 is not equal to m2. Since the sign of the difference is not important, the test will be two-sided.
详细描述
General Information
Antibodies are a specific response to any "foreign" antigen, and they are usually detectable in the serum within 5-7 days after the initial exposure to it. However, there are some cases where there is a suppression of the specific immune response, such as in the case of a tumor. To date, there are no reports on serum antibodies that are associated to cancer. Some tumors, when surgically removed and studied have been found to have both infiltrates of T lymphocytes and antibodies bound to the tumor cells. These antibodies (and other specific immune responses) are assumed to be formed at later stages of the tumor growth, however, even in those cases, serum antibodies have not been reported (probably due to them being mostly "absorbed" by the tumor mass).
Since the mutations of a normal cell that lead to a malignant cell mass 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 determinants that should be responded against; if so, than the suppression caused by the tumor would be the reason for the lack of antibodies.
If this immune suppression could be overcome, in vitro, it could lead to the formation of antibodies that are not detectable in the serum (we call this process Cimmunology). Identifying the structures that the antibodies bind to, and looking for a correlation between the tumor pathology and the antibodies' specificity - could provide additional information about the tumor - via a blood test.
Future CAAb Test
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Other
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
- •Ovarian cancer patients:
- •Subjects 18 years or over.
- •Patients suspected of ovarian cancer (including peritoneal carcinoma). The clinical suspicion will include one of the following: pelvic mass (by pelvic examination or other imaging techniques), or high cancer antigen (CA)-125 levels in post-menopausal women, ascites, or due to incidental finding of distant metastasis. Final analysis will be done in relation to pathology only.
- •Patients willing to participate as evidenced by signing the written informed consent.
- •Control subjects:
- •Subjects 18 years or over
- •Patients willing to participate as evidenced by signing the written informed consent
排除标准
- •Ovarian cancer patients:
- •Subjects less than 18 years of age
- •Hematological malignancies
- •Previous ovarian tumor
- •Patients under active chemotherapy treatment
- •Patients not willing to sign written informed consent
- •Control subjects:
- •Subjects less than 18 years
- •Hematological malignancies
- •History of any past tumors
- •Other ovarian pathology
- •Patients who have been under anesthesia in the last 2 months
- •Patients treated with immunosuppressant drugs
- •Patients not willing to sign written informed consent