Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 4
- 主要终点
- Tumor Marker HE4
研究概览
简要总结
Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor.
To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease.
The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.
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
- 否
入选标准
- •patients to undergo surgery for an ovarian cyst
- •presumed benign ovarian tumor (according to the rules of the IOTA(International Ovarian Tumor Analysis Group) group)
- •agreement to participate in the study
排除标准
- •pregnant patient
- •minor patient
- •Patient under guardianship, trusteeship, or deprived of liberty
- •Patient with ascites or metastases or malignant ovarian mass presumed under the rules of IOTA group.
- •Patient with an adnexal torsion is suspected
- •Patient unable to understand the proposed study
结局指标
主要结局
Tumor Marker HE4
时间窗: Baseline
HE4 \< 70 pmol/L for premenopausal women or \< 140 pmol/L for postmenopausal women Abnormal score if HE4 \> 70 pmol/L for premenopausal women or \> 140 pmol/L for postmenopausal women
Tumor Marker CA125
时间窗: Baseline
CA125 \< 35U/mL. Abnormal score if CA125 \> 35U/mL.
次要结局
未报告次要终点