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

This study has suspended participant recruitment.
(Because of economic issue, we could just enrolled total 150 patients.)
Sponsor:
Information provided by (Responsible Party):
Seok Jin Nam, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01137136
First received: June 2, 2010
Last updated: April 18, 2014
Last verified: April 2014
  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: April 18, 2014
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 July 22, 2014