Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- P-gp expression in blood samples
研究概览
简要总结
Determine P-glycoprotein expression in blood samples of Acute Lymphocytic leukemia (ALL) pediatric patients receiving MTX treatment and trace its ontogeny and compare it with its expression in pediatric healthy subjects. In addition, to determine the correlation of P-glycoprotein expression and Methotrexate concentration at steady state.
详细描述
The 20 leukemic patients will be classified into three age groups according to the ages that will be available at the time of sample collection.
- All patients will be recruited from Tanta Oncology Center, Tanta University.
- The study will be approved by the Research Ethics Committee of Tanta University and college of Pharmacy ethical committee.
- An informed consent will be obtained from parents of all patients in this research before enrollment.
- All patients' data will be private and confidential. Any unexpected risks that may appear during the course of the research will be reported to patients and the ethical committee on time.
Blood Samples will be obtained from healthy pediatric subjects of the same ages of the diseased group subjects (Samples will be obtained from subjects from a primary care center during their routine blood analysis excluding patients of chronic diseases, patients receiving any medications, and patients of impaired kidney or liver functions).
P-glycoprotein expression will be estimated in all samples using Permeability glycoprotein (P-gp), ELISA Kit, and its expression will be traced with development from the youngest till the oldest age available, this will also be compared with normal healthy pediatric subjects.
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
- 1 Month 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric Acute Lymphocytic Leukemia Patients
- •aged < 18 years old
- •who are already taking the ALL MTX protocol.
排除标准
- •Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)
- •Critically ill patients.
- •Other types of cancer
结局指标
主要结局
P-gp expression in blood samples
时间窗: 42 hours
P-gp expression in blood samples
Methotrexate concentration in blood samples
时间窗: 42 hours
Methotrexate concentration in blood samples
次要结局
未报告次要终点
研究者
Yasmine Elmorsi
Principal Investigator
Tanta University
