跳至主要内容
临床试验/NCT00973505
NCT00973505Unknown不适用

Significance of CYP19 Genetic Polymorphism on Musculoskeletal Symptom & Complication of Aromatase Inhibitor(AI)

Korea University Anam Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年3月最近更新:
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

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

申办方类型
Other

研究点 (1)

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