- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181518
Tamoxifen Pharmacogenetics in Asian Breast Cancer Women (Tamoxifen)
May 31, 2013 updated by: Jae-Gook Shin, Inje University
Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients
The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.
Study Overview
Status
Unknown
Detailed Description
The investigators investigated the prognostic and/or predictive value of genetic polymorphisms of enzymes involved in tamoxifen metabolism for the treatment outcome among Asian breast cancer patients.
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ji-Yeob Choi, Ph.D.
- Phone Number: 82-51-890-8663
- Email: jychoi@inje.ac.kr
Study Locations
-
-
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Busan, Korea, Republic of, 614-735
- Recruiting
- Inje University
-
Contact:
- Ji-Yeob Choi, Ph.D.
- Phone Number: 82-51-890-8663
- Email: jychoi@inje.ac.kr
-
Principal Investigator:
- Jae-Gook Shin, MD,PhD
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Breast cancer patients who underwent surgery at Busan Paik Hospital, Inje University
Description
Inclusion Criteria:
- incident breast cancer patients who underwent surgery
Exclusion Criteria:
- previous cancer history before breast cancer diagnosis
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients
Time Frame: five years
|
Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2010
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 12, 2010
First Submitted That Met QC Criteria
August 12, 2010
First Posted (Estimate)
August 13, 2010
Study Record Updates
Last Update Posted (Estimate)
June 3, 2013
Last Update Submitted That Met QC Criteria
May 31, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-140
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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