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Tamoxifen Pharmacogenetics in Asian Breast Cancer Women (Tamoxifen)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Jae-Gook Shin, Inje University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181518
First Posted: August 13, 2010
Last Update Posted: June 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
  Purpose
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
Poisoning by, Adverse Effect of and Underdosing of Tamoxifen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Jae-Gook Shin, Inje University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 1000
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Contact: Ji-Yeob Choi, Ph.D. 82-51-890-8663 jychoi@inje.ac.kr

Locations
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
Principal Investigator: JaeGook Shin, MD,PhD Inje University
  More Information

Responsible Party: Jae-Gook Shin, Professor, Inje University
ClinicalTrials.gov Identifier: NCT01181518     History of Changes
Other Study ID Numbers: 09-140
First Submitted: August 12, 2010
First Posted: August 13, 2010
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:
Breast Neoplasms
Poisoning
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Chemically-Induced Disorders
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents