Trials / Completed
CompletedNCT02263846
Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,183 (actual)
- Sponsor
- Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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).
Conditions
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2014-10-13
- Last updated
- 2015-04-13
Source: ClinicalTrials.gov record NCT02263846. Inclusion in this directory is not an endorsement.