Poisoning by, Adverse Effect of and Underdosing of TamoxifenTamoxifenNCT01181518
Tamoxifen Pharmacogenetics in Asian Breast Cancer Women
An observational study of Poisoning by, Adverse Effect of and Underdosing of Tamoxifen, run by Inje University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Poisoning by, Adverse Effect of and Underdosing of Tamoxifen
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who underwent surgery at Busan Paik Hospital, Inje University
Who may be able to join
- incident breast cancer patients who underwent surgery
Who cannot join
- previous cancer history before breast cancer diagnosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inje University
Busan, Busan, 614-735
Ji-Yeob Choi, Ph.D., 82-51-890-8663, jychoi@inje.ac.kr
Jae-Gook Shin, MD,PhD
About this study
Official title: 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.
Read the 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.
- Keywords
- Tamoxifen, Pharmacogenomics, Breast cancer
- Medical subject headings
- Poisoning, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients
Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poisoning by, Adverse Effect of and Underdosing of TamoxifenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- JaeGook Shin, MD,PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181518
- Sponsor's protocol ID
- 09-140
- Acronym
- Tamoxifen
- Status last verified
- May 2013
- First submitted
- 12 Aug 2010
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01181518
- Acronym / sponsor ID
- Tamoxifen / 09-140
- Keywords
- Tamoxifen, Pharmacogenomics, Breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who underwent surgery at Busan Paik Hospital, Inje University
Key inclusion criteria (1 listed)
- incident breast cancer patients who underwent surgery
Key exclusion criteria (1 listed)
- previous cancer history before breast cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JaeGook Shin, MD,PhD principal investigator
Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poisoning by, Adverse Effect of and Underdosing of Tamoxifen, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Yeob Choi, Ph.D. (82-51-890-8663, jychoi@inje.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.