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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00973505
Other study ID # AN09021
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2009
Last updated September 8, 2009
Start date March 2009
Est. completion date September 2010

Study information

Verified date September 2009
Source Korea University Anam Hospital
Contact Eun Sook Lee, MD, PhD
Phone 82-2-920-6744
Email eslee@korea.ac.kr
Is FDA regulated No
Health authority Republic of Korea: Institutional Review Board
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Aromatase Inhibitor(Femara or Arimidex)
Femara(Letrozole) 2.5mg 1tab qd, Arimidex(Anastrozole) 1mg 1tab qd

Locations

Country Name City State
Korea, Republic of Korea University Anam Hopital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Korea University Anam Hospital Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level 6, 12 months No
Secondary EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI 3,6,12 months No
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