ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01137136
Recruitment Status : Suspended (Because of economic issue, we could just enrolled total 150 patients.)
First Posted : June 4, 2010
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Seok Jin Nam, Samsung Medical Center

Brief 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.

Condition or disease
Polymorphism CYP19 Aromatase Inhibitor

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea
Study Start Date : June 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
SMAC (SMc AI user Cohort)
All patients who took the AI (Aromatase inhibitor)will be enrolled



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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137136


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

Responsible Party: Seok Jin Nam, Professor, M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01137136     History of Changes
Other Study ID Numbers: 2009-11-035
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014