PolymorphismCYP19NCT01137136
Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea
An observational study of Polymorphism and CYP19, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polymorphism, CYP19, Aromatase Inhibitor
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 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 Up to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Postmenopausa women who underwent surgery for breast cancer
Who may be able to join
- hormone receptor positiveBreast cancer patient
- postmenopausal women
- first user of aromatase inhibitor
Who cannot join
- premenopausal
- The patient who take the other antihormonal therapy
- osteoporosis patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Polymorphism, CYP19, Aromatase Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SMAC (SMc AI user Cohort) | All patients who took the AI (Aromatase inhibitor)will be enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of CYP19 polymorphism
Measured: 12. 31. 2011
Secondary outcomes (1)
The effect of CYP19 polymorphism to the prognosis of AI user
Measured: 12. 31. 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Because of economic issue, we could just enrolled total 150 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymorphismStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Jin Nam, Samsung Medical Center
- Investigators
- Seok Jin Nam, M.D., Ph.D., Study director, Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137136
- Sponsor's protocol ID
- 2009-11-035
- Acronym
- CYP19
- Status last verified
- Apr 2014
- First submitted
- 2 Jun 2010
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea
- ClinicalTrials.gov ID
- NCT01137136
- Acronym / sponsor ID
- CYP19 / 2009-11-035
- Conditions
- Polymorphism, CYP19, Aromatase Inhibitor
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Because of economic issue, we could just enrolled total 150 patients.
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Jun 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMAC (SMc AI user Cohort) | – | –All patients who took the AI (Aromatase inhibitor)will be enrolled |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausa women who underwent surgery for breast cancer
Key inclusion criteria (3 listed)
- hormone receptor positiveBreast cancer patient
- postmenopausal women
- first user of aromatase inhibitor
Key exclusion criteria (3 listed)
- premenopausal
- The patient who take the other antihormonal therapy
- osteoporosis patients
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
The prevalence of CYP19 polymorphism
Time frame: 12. 31. 2011
1 secondary outcome
The effect of CYP19 polymorphism to the prognosis of AI user
Time frame: 12. 31. 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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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.
Seok Jin Nam, M.D., Ph.D. study director
Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Surgery
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 Polymorphism and CYP19, run by Samsung Medical Center 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 3 inclusion and 3 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: paused, as of the sponsor's last update on 21 Apr 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of CYP19 polymorphism (time frame: 12. 31. 2011). 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 21 Apr 2014.