- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973505
CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI) (AI-CYP19)
September 8, 2009 updated by: Korea University Anam Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eun Sook Lee, MD, PhD
- Phone Number: 82-2-920-6744
- Email: eslee@korea.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of, 136-705
- Recruiting
- Korea University Anam Hopital
-
Contact:
- Eun Sook Lee, MD, PhD
- Phone Number: 82-2-920-6744
- Email: eslee@korea.ac.kr
-
Principal Investigator:
- Eun Sook Lee, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Breast cancer patients taking the medication of AI (aromatase inhibitor) in post menopause status.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CYP19
CYP19 genetic polymorphism
|
Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level
Time Frame: 6, 12 months
|
6, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3,6,12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eun Sook Lee, MD, PhD, Korea University Anam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
September 1, 2010
Study Completion (Anticipated)
September 1, 2010
Study Registration Dates
First Submitted
September 8, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
September 9, 2009
Last Update Submitted That Met QC Criteria
September 8, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Pain
- Neurologic Manifestations
- Breast Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Breast Neoplasms
- Arthritis
- Arthralgia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Anastrozole
- Aromatase Inhibitors
Other Study ID Numbers
- AN09021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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