Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,183
- 主要终点
- The capability of sex hormones to discriminate between pre- and postmenopausal women with invasive breast cancer measured by four widely used methods and instruments in China.
研究概览
简要总结
This study is to investigate sex hormones levels of Chinese patients with invasive breast cancer.The aim is to analyze biochemical monitoring results of premenopausal and postmenopausal patients to facilitate determination of menopausal status and propose clinical application.
详细描述
Follicle stimulating hormone (FSH), estradiol (E2) and luteinizing hormone (LH) can serve as indicators in the determination of menopausal status. NCCN clinical practice guidelines for breast cancer recommend detecting the levels of FSH and E2 for amenorrhea patients less than 60 years of age. But the detection method and the corresponding reference ranges indicating postmenopausal status are not mentioned. In addition, the reference limits vary a lot among different equipments and methods when it comes to diagnosis of menopause, thus it is difficult to set universal criteria. So in this study, four widely used methods and instruments in China are used to detect plasma levels of FSH, E2 and LN of premenopausal and postmenopausal patients. Instruments and methods must be one of the following four categories: microparticle chemiluminescent(Beckman),acridinium ester chemiluminescence (Siemens),acridinium ester chemiluminescence (Abbott) and electrochemiluminescence（Roche）.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive breast cancer patients confirmed through pathology.
- •For postmenopausal group: patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.
- •For premenopausal group: patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone (LHRH) analogue therapy.
- •Patients who meet the above criteria can be enrolled whether they have received anti-cancer treatment or not.
排除标准
- •patients less than 60 years old who are amenorrhoeic but have not received bilateral oophorectomy or medical castration.
结局指标
主要结局
The capability of sex hormones to discriminate between pre- and postmenopausal women with invasive breast cancer measured by four widely used methods and instruments in China.
时间窗: Two years
Distribution characteristics of three hormones in pre- and postmenopausal patients are described with Kernel density estimation. Their discrimination capabilities are evaluated with operating characteristics (ROC) curve.
次要结局
未报告次要终点