NCT00973505Unknown不适用
Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
CYP19
CYP19 genetic polymorphism
干预措施: Aromatase Inhibitor(Femara or Arimidex) (Drug)
结局指标
主要结局
Change of SNPs (PCR & sequencing), Estrogen, Inflammatory Cytokine level
时间窗: 6, 12 months
次要结局
- EORTC (European Organization for Research and Treatment of Cancer)- QOL(Quality of Life)- C30, BR23 & Skeletal pain information, BMI(3,6,12 months)
研究者
研究点 (1)
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