NCT00228930已完成不适用
A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects
National Institute of General Medical Sciences (NIGMS)2 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2002年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 试验地点
- 2
研究概览
简要总结
The purpose of this research is to try to identify which women who take tamoxifen are likely to suffer from hot flashes or are more likely to have other side effects or benefits from the drug. The researchers will do so by determining whether there are mutations that normally occur in human DNA that might influence the way individuals respond to medications.
详细描述
The study will test the following hypotheses.
- There is a relationship between genetically distinct metabolic profiles of tamoxifen and the frequency and severity of hot flashes in women on chronic tamoxifen therapy.
- Genetically distinct metabolic profiles for tamoxifen effect lipid profile, bone turnover metabolites and bone mineral density, and coagulation factors.
- Different genetic profiles of estrogen responsive genes influence the pharmacodynamic effects of tamoxifen in cardiovascular system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-years or older
- •Women with a prior breast cancer or who are at a high risk for developing the disease and about to start tamoxifen therapy.
- •Participants must not be treated with concomitant chemotherapy or hormone therapy other than tamoxifen. They must not have ovarian ablation or currently being treated with radiation therapy and/or chronic corticosteroids.
- •The participant must not be taking anti-hot flash therapy (clonidine, bellergal, megestrol acetate). Vitamin E, selective serotonin reuptake inhibitors, or herbal remedies are allowed provided that the participant has been taking the remedy for at least 4 weeks and intends to continue the remedy for at least the first month while on the study, and allows for one-month follow up evaluation (hot flash diaries and blood samples).
- •The participant must not be pregnant or lactating.
- •The participant is able and willing to sign an informed consent.
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Tamoxifen Pharmacogenetics in Asian Breast Cancer WomenPoisoning by, Adverse Effect of and Underdosing of TamoxifenNCT01181518Inje University1,000
已完成
1 期
Karolinska Interventional Study of Mammograhic Density (Karisma-1)Mammographic DensityBreast CancerNCT04079517Karolinska Institutet42
已完成
不适用
A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6Breast CancerNCT00900744Icahn School of Medicine at Mount Sinai121
Unknown
不适用
CYP2D6 Genotyping by AmpliChipTM CYP450 for Tamoxifen-Treated Breast Cancer PatientsBreast CancerNCT00815555Assaf-Harofeh Medical Center500
终止
2 期
Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer RiskBreast Atypical HyperplasiaBreast Lobular Carcinoma in SituBreast Atypical Lobular HyperplasiaBreast CarcinomaNCT04570956Mayo Clinic65