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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263846
• Other study ID #: CBCSG008
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: April 9, 2015
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: April 2015
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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）.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1183
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	Chinese Anti-Cancer Association

References & Publications (1)

Smith IE, Dowsett M, Yap YS, Walsh G, Lønning PE, Santen RJ, Hayes D. Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: caution and suggested guidelines. J Clin Oncol. 2006 Jun 1;24(16):2444-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No