Clinical Trials Directory

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.