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Trial Title:
CYP19 Genetic Polymorphism & Aromatase Inhibitor(AI)
NCT ID:
NCT00973505
Condition:
Breast Neoplasms
Arthralgia
Arthritis
Genetic Polymorphism
Conditions: Official terms:
Breast Neoplasms
Arthritis
Arthralgia
Anastrozole
Aromatase Inhibitors
Conditions: Keywords:
Breast neoplasms
Aromatase inhibitors
Genetic polymorphisms
Arthralgia
Arthritis
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Aromatase Inhibitor(Femara or Arimidex)
Description:
Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd
Arm group label:
CYP19
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.
Criteria for eligibility:
Study pop:
Breast cancer patients taking the medication of AI (aromatase inhibitor) in post
menopause status.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. The patient must sign the informed consent.
2. The patient must sign the informed consent of genetic screening test.
3. The patient must be between 18 years old and 80 years old who can make a decision
independently.
4. The patient must be post-menopause status.
5. The patient should be the stage 1,2 or 3 of the breast cancer.
6. 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:
1. The patient is pre-menopause status.
2. The test result of serum FSH level is below 30mU/ml.
3. The test result of the hormone receptor(ER & PR) is negative or unknown.
4. Patient's breast cancer stage is 4 which has systemic metastatics.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Korea University Anam Hopital
Address:
City:
Seoul
Zip:
136-705
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eun Sook Lee, MD, PhD
Phone:
82-2-920-6744
Email:
eslee@korea.ac.kr
Investigator:
Last name:
Eun Sook Lee, MD, PhD
Email:
Principal Investigator
Start date:
March 2009
Completion date:
September 2010
Lead sponsor:
Agency:
Korea University Anam Hospital
Agency class:
Other
Collaborator:
Agency:
Korea University
Agency class:
Other
Source:
Korea University Anam Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00973505
