Identification and Characterization of Ovarian Cancer and Endometrial Cancer Specific Biomarkers in Vaginal Fluids
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The difference in the levels of the Human Epididymis Protein 4 (HE4) measured between healthy patients and ovary cancer patients. Measuring units will be pmol/L.
研究概览
简要总结
The purpose of this study is to:
- Identification and characterization of ovarian carcinoma well-known biomarkers, carcinoma antigen 125 (CA125) and Human epididymis protein 4 (HE4) and other potential biomarkers in vaginal fluids obtained from ovarian cancer patients.
- Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients in comparisons to samples collected from healthy volunteers.
- Comparison analysis of biomarkers levels in vaginal fluids vs. serum.
- Quantification and calibration of identified biomarkers in vaginal discharge collected from ovarian cancer patients diagnosed in various stages.
详细描述
Initially, twenty vaginal fluid samples will be collected from ovarian cancer patients diagnosed with epithelial ovarian carcinoma at advanced diagnosis stage.
The samples will be used to identify specific biomarkers as describe above. Biomarkers levels will be calibrated compared to their vaginal fluids obtained from healthy volunteers. In addition, five milliliters of venous blood will be collected from same patients in order to compare biomarkers vaginal fluids levels vs serum levels. All patients will sign a consent form which approve that their vaginal fluid samples will be utilized for research according to Helsinki approval.
At the second phase of the research, additional twenty vaginal fluids samples will be collected from patients diagnosed at different stages (five samples from each of main stages 1-4). Sample will be used to calibrate biomarkers levels in various diagnosis stages and will be compare to serum levels from venous blood samples which will be also collected from the same patients.
All patients will sign a consent form following explanation on research goals. Patient will be notified that participation in this research will have no implication on medical treatment plan.
Note that in all research phases there will be no returning of samples to the patients, all identification and characterization procedures will be performed in vitro for research properties only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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 carcinoma (in the "disease" arm)
排除标准
- 未提供
结局指标
主要结局
The difference in the levels of the Human Epididymis Protein 4 (HE4) measured between healthy patients and ovary cancer patients. Measuring units will be pmol/L.
时间窗: 1 year
The difference in the levels of the glycoprotein CA-125 between healthy patients and ovary cancer patients. The measuring units will be U/mL.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Shachar Finci
Principal Investigator
Shaare Zedek Medical Center