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Tamoxifen Pharmacogenetics in Asian Breast Cancer Women (Tamoxifen)

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ClinicalTrials.gov Identifier: NCT01181518
Recruitment Status : Unknown
Verified May 2013 by Jae-Gook Shin, Inje University.
Recruitment status was:  Recruiting
First Posted : August 13, 2010
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University

Study Description
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Brief Summary:
The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.

Condition or disease
Poisoning by, Adverse Effect of and Underdosing of Tamoxifen

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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients
Study Start Date : August 2010
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Tamoxifen

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Blood samples for genotyping and pharmacokinetic analysis

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer patients who underwent surgery at Busan Paik Hospital, Inje University
Criteria

Inclusion Criteria:

  • incident breast cancer patients who underwent surgery

Exclusion Criteria:

  • previous cancer history before breast cancer diagnosis
Contacts and Locations
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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): NCT01181518


Contacts
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Contact: Ji-Yeob Choi, Ph.D. 82-51-890-8663 jychoi@inje.ac.kr

Locations
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Korea, Republic of
Inje University Recruiting
Busan, Korea, Republic of, 614-735
Contact: Ji-Yeob Choi, Ph.D.    82-51-890-8663    jychoi@inje.ac.kr   
Principal Investigator: Jae-Gook Shin, MD,PhD         
Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: JaeGook Shin, MD,PhD Inje University
More Information
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Responsible Party: Jae-Gook Shin, Professor, Inje University
ClinicalTrials.gov Identifier: NCT01181518    
Other Study ID Numbers: 09-140
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013
Keywords provided by Jae-Gook Shin, Inje University:
Tamoxifen
Pharmacogenomics
Breast cancer
Additional relevant MeSH terms:
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Poisoning
Chemically-Induced Disorders