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

Study Overview
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Brief Summary
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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
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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）.

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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postmenopausal group<br>Patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy. | |
| Premenopausal group<br>Patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone analogue therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Menopause, Estradiol, Follicle stimulating hormone