Breast NeoplasmsAI-CYP19NCT00973505
CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)
An observational study of Breast Neoplasms and Arthralgia, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms, Arthralgia, Arthritis
- What is being tested?
- Aromatase Inhibitor(Femara or Arimidex)
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Sep 2010
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients taking the medication of AI (aromatase inhibitor) in post menopause status.
Who may be able to join
- The patient must sign the informed consent.
- The patient must sign the informed consent of genetic screening test.
- The patient must be between 18 years old and 80 years old who can make a decision independently.
- The patient must be post-menopause status.
- The patient should be the stage 1,2 or 3 of the breast cancer.
- The test result of the estrogen receptor or progesterone receptor is positive, so the patient should be taking the medication of AI (Aromatase Inhibitor).
Who cannot join
- The patient is pre-menopause status.
- The test result of serum FSH level is below 30mU/ml.
- The test result of the hormone receptor(ER \& PR) is negative or unknown.
- Patient's breast cancer stage is 4 which has systemic metastatics.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hopital
Seoul, 136-705
Eun Sook Lee, MD, PhD, 82-2-920-6744, eslee@korea.ac.kr
Eun Sook Lee, MD, PhD
About this study
Official title: Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)
The purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.
- Conditions
- Breast Neoplasms, Arthralgia, Arthritis, Genetic Polymorphism
- Being tested
- Aromatase Inhibitor(Femara or Arimidex)
- Keywords
- Breast neoplasms, Aromatase inhibitors, Genetic polymorphisms, Arthralgia, Arthritis
- Medical subject headings
- Breast Neoplasms, Arthralgia, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatase Inhibitor(Femara or Arimidex)Drug
Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd
| Study group | Role | What they receive |
|---|---|---|
| CYP19 | CYP19 genetic polymorphism Receives: Drug: Aromatase Inhibitor(Femara or Arimidex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level
Measured: 6, 12 months
Secondary outcomes (1)
EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University
- Investigators
- Eun Sook Lee, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973505
- Sponsor's protocol ID
- AN09021
- Acronym
- AI-CYP19
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)
- ClinicalTrials.gov ID
- NCT00973505
- Acronym / sponsor ID
- AI-CYP19 / AN09021
- Conditions
- Breast Neoplasms, Arthralgia, Arthritis, Genetic Polymorphism
- Keywords
- Breast neoplasms, Aromatase inhibitors, Genetic polymorphisms, Arthralgia, Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Korea University
- Study start
- Mar 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 9 Sep 2009 (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 purpose of this study is to investigate the relationship between the side effects(especially arthralgia and arthritis) which appear in the patients who are prescribed aromatase inhibitor(AI) and the CYP19 genetic polymorphisms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CYP19 | – | Drug: Aromatase Inhibitor(Femara or Arimidex)CYP19 genetic polymorphism |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients taking the medication of AI (aromatase inhibitor) in post menopause status.
Key inclusion criteria (6 listed)
- The patient must sign the informed consent.
- The patient must sign the informed consent of genetic screening test.
- The patient must be between 18 years old and 80 years old who can make a decision independently.
- The patient must be post-menopause status.
- The patient should be the stage 1,2 or 3 of the breast cancer.
Key exclusion criteria (4 listed)
- The patient is pre-menopause status.
- The test result of serum FSH level is below 30mU/ml.
- The test result of the hormone receptor(ER \& PR) is negative or unknown.
- Patient's breast cancer stage is 4 which has systemic metastatics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatase Inhibitor(Femara or Arimidex)Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd | Drug | CYP19 |
Primary outcome
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level
Time frame: 6, 12 months
1 secondary outcome
EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI
Time frame: 3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
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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.
Eun Sook Lee, MD, PhD principal investigator
Korea University Anam Hospital
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 Breast Neoplasms and Arthralgia, run by Korea University Anam Hospital 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 6 inclusion and 4 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 9 Sep 2009. 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 Eun Sook Lee, MD, PhD (82-2-920-6744, eslee@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level (time frame: 6, 12 months). 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 9 Sep 2009.