Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02263846
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief 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）.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1183

Inclusion Criteria

• 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.

Exclusion Criteria

• patients less than 60 years old who are amenorrhoeic but have not received bilateral oophorectomy or medical castration.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.