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NCT01137136 Clinical Trial

Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea

Polymorphism Clinical Trial

— CYP19  

Official title:
Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01137136
Other study ID # 2009-11-035
Secondary ID
Status Suspended
Phase N/A
First received June 2, 2010
Last updated April 18, 2014
Start date June 2010
Est. completion date December 2015

Study information
Verified date April 2014
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutiona Review Board
Study type Observational

Clinical Trial Summary

Aromatase(CYP19)inhibitor is one of the major antihormonal drug for breast cancer in postmenopausal women. The variation of CYP19 may affect the effect of aromatase inhibitor. However, the incidence of variation of CYP19 in Korea has not known. Therefore, the investigators want to know the incidence of variation of CYP19 and to assess the effect of these variations of CYP19 to aromatase inhibitor users.

Recruitment information / eligibility
Status Suspended
Enrollment 300
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 80 Years
Eligibility Inclusion Criteria:

- hormone receptor positiveBreast cancer patient

- postmenopausal women

- first user of aromatase inhibitor

Exclusion Criteria:

- premenopausal

- The patient who take the other antihormonal therapy

- osteoporosis patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The prevalence of CYP19 polymorphism 12. 31. 2011 No
Secondary The effect of CYP19 polymorphism to the prognosis of AI user 12. 31. 2016 No
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