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

This study has suspended participant recruitment.
(Because of economic issue, we could just enrolled total 150 patients.)
Information provided by (Responsible Party):
Seok Jin Nam, Samsung Medical Center Identifier:
First received: June 2, 2010
Last updated: April 18, 2014
Last verified: April 2014
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.

Aromatase Inhibitor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea

Resource links provided by NLM:

Further study details as provided by Seok Jin Nam, Samsung Medical Center:

Primary Outcome Measures:
  • The prevalence of CYP19 polymorphism [ Time Frame: 12. 31. 2011 ]

Secondary Outcome Measures:
  • The effect of CYP19 polymorphism to the prognosis of AI user [ Time Frame: 12. 31. 2016 ]

Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
SMAC (SMc AI user Cohort)
All patients who took the AI (Aromatase inhibitor)will be enrolled


Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausa women who underwent surgery for breast cancer

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01137136

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Study Director: Seok Jin Nam, M.D., Ph.D. Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Surgery
  More Information

Responsible Party: Seok Jin Nam, Professor, M.D., Ph.D., Samsung Medical Center Identifier: NCT01137136     History of Changes
Other Study ID Numbers: 2009-11-035
Study First Received: June 2, 2010
Last Updated: April 18, 2014 processed this record on May 25, 2017