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

Completed

• Conditions: Acute Lymphocytic Leukemia
• Interventions: Other: MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)

• Registration Number: NCT05021159
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-06-01
• Status Verified: 2021-08
• Study Completion: 2021-08-01
• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-25
• Last Update Submitted: 2021-08-28
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Pediatric Acute Lymphocytic Leukemia Patients
• aged < 18 years old
• who are already taking the ALL MTX protocol.

Exclusion Criteria

• Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)

  • Critically ill patients.
  • Other types of cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Methotrexate Group	MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)	20 acute lymphocytic leukemia patients receiving MTX treatment (3- 5 mg/ cm2)

Primary Outcome Measures

Name	Time	Method
P-gp expression in blood samples	42 hours	P-gp expression in blood samples
Methotrexate concentration in blood samples	42 hours	Methotrexate concentration in blood samples

Trial Locations

Locations (3)

Tanta Cancer Center; 🇪🇬 Tanta, Gharbiya, Egypt

Tanta University; 🇪🇬 Tanta, Gharbiya, Egypt

Faculty of Pharmacy, Tanta University; 🇪🇬 Tanta, Gharbiya, Egypt