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

NCT02263846 | Completed

• 1 other identifier: CBCSG008
• Study Type: observational
• Target: 1,183
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Menopause; Estradiol; Follicle stimulating hormone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Postmenopausal group

Patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.

Premenopausal group

Patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone analogue therapy.

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese women with invasive breast cancer.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead
• Chinese Anti-Cancer Association: collaborator

Related Publications (1)

• Smith IE, Dowsett M, Yap YS, Walsh G, Lonning 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. doi: 10.1200/JCO.2005.05.3694.

  PMID: 16735701 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Santai Song

  Affiliated Hospital to Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 13, 2015

Record last verified: 2015-04