Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea
This study is currently recruiting participants.
Verified June 2013 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Seok Jin Nam, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01137136
First received: June 2, 2010
Last updated: June 9, 2013
Last verified: June 2013
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Purpose
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 |
|---|
|
Polymorphism CYP19 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 Samsung Medical Center:
Primary Outcome Measures:
- The prevalence of CYP19 polymorphism [ Time Frame: 12. 31. 2011 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The effect of CYP19 polymorphism to the prognosis of AI user [ Time Frame: 12. 31. 2016 ] [ Designated as safety issue: No ]
| 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) |
| Groups/Cohorts |
|---|
|
SMAC (SMc AI user Cohort)
All patients who took the AI (Aromatase inhibitor)will be enrolled
|
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137136
Contacts
| Contact: Seok Jin Nam, M.D., Ph.D. | 82-2-3410-3479 | seokjin.nam@samsung.com |
| Contact: Se Kyung Lee, M.D. | 82-2-3410-0926 | sekyung.lee@samsung.com |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Seok Jin Nam, M.D., Ph.D. 82-2-3410-3479 seokjin.nam@samsung.com | |
| Contact: Se Kyung Lee, M.D. 82-2-3410-0926 sekyung.lee@samsung.com | |
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 |
More Information
No publications provided
| 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 |
| Study First Received: | June 2, 2010 |
| Last Updated: | June 9, 2013 |
| Health Authority: | South Korea: Institutiona Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013