跳至主要内容
临床试验/NCT05021159
NCT05021159已完成不适用

Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients

Tanta University3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasmine Elmorsi

Principal Investigator

Tanta University

研究点 (3)

Loading locations...

相似试验