Multicenter Clinical Research for Diagnosis of Epithelial Ovarian Cancer Using OCS Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,352
- 试验地点
- 1
- 主要终点
- the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value.
研究概览
简要总结
The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study.
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
- •a) ≥ 18 years of age;
- •b) Patients with adnexal masses;
- •c) Sign the informed consent form;
- •d) Adnexal mass that requires excision;
排除标准
- •a) history of chemoradiotherapy;
- •b) history of malignancy;
- •c) pregnancy;
- •d) Adnexal mass not require surgical excision;
- •e) The adnexal mass has been diagnosed as malignant before surgery, and the number of cases enrolled in a single institution exceeds 50;
- •f) Blood CA125 value greater than 1000 U/ml at initial treatment.
结局指标
主要结局
the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value.
时间窗: Data analysis would be completed in three months after all data were collected.
Evaluation of the performance of the OCS value in discriminating between benign and malignant tumors. Serum was collected before surgery. The serum OCS value was calculated with the serum level of extracellular vesicle biomarkers using a preset formula. The unit for each EV biomarker in the formula was as follows: Carbohydrate antigen 125 (CA125, U/ml), Human Epididymis Protein (HE4, pmol/L) and Complement Component 5a (5a, ng/ml). The OCS value was a numerical value witout units. The OCS value above the preset cut-off (0.506) value indicated maligant tumor, otherwise the adnexal mass was benign. The concordance between the pathological results (gold standard) and the results predicted by the OCS value was compared.
次要结局
未报告次要终点