Effects of Pharmacogenetics on Pharmacokinetics and Toxicity of Doxorubicin in Egyptian Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Doxorubicin plasma concentrations
研究概览
简要总结
This study aims to investigate the effect of single nucleotide polymorphisms (SNPs) of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients.
It also aims to explore the association of pretreatment neutrophil to lymphocyte ratio (NLR) with pathological complete response (pCR).
详细描述
Plasma concentrations of doxorubicin will be determined and venous blood samples will be obtained from each patient for SNP genotyping of genes involved in doxorubicin transport and metabolism on its pharmacokinetics and toxicity in Egyptian breast cancer patients [prospective study].
A complete blood count was carried out at baseline for patients receiving neoadjuvant chemotherapy. The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes [ retrospective study].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged ≥ 18 years
- •Performance status 0 or 1
- •No contraindication to chemotherapy
- •Adequate bone marrow
- •Adequate hepatic function
- •Adequate renal function
排除标准
- •Poorly controlled diabetes mellitus
- •Ischemic heart disease
- •Uncontrolled hypertension
- •Active infections
- •Baseline ejection fraction < 50%
- •Performance status ≥ 2
- •Pregnancy Lactation, bilateral breast cancer, male patients, primary surgery, distant metastases, other malignancies, inflammations, hematological disorders, autoimmune diseases, and patients taking non-steroidal anti-inflammatory drugs (NSAIDs), steroidal and antibiotic therapy.
结局指标
主要结局
Doxorubicin plasma concentrations
时间窗: baseline
Plasma concentrations of doxorubicin will be determined using a suitable analytical method.
neutrophil to lymphocyte ratio
时间窗: baseline
The neutrophil to lymphocyte ratio (NLR) was calculated as the ratio between the absolute count of neutrophils and the absolute count of lymphocytes.
次要结局
未报告次要终点
研究者
Naglaa Fathy Mohamed Ebaid
Assistant Lecturer of clinical pharmacy
Menoufia University