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

April 18, 2014 updated by: Seok Jin Nam, Samsung Medical Center
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.

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenopausa women who underwent surgery for breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The prevalence of CYP19 polymorphism
Time Frame: 12. 31. 2011
12. 31. 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of CYP19 polymorphism to the prognosis of AI user
Time Frame: 12. 31. 2016
12. 31. 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Study Director: Seok Jin Nam, M.D., Ph.D., Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (ESTIMATE)

June 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2009-11-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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