Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 10:28 PM
Study NCT ID:
NCT05021159
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2021-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: