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

Tanta University

Status: Completed

Conditions: Acute Lymphocytic Leukemia

Treatments: 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)

Study type: Observational

Funder types: Other

Identifiers

NCT05021159

141052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Methotrexate Group

Description:

20 acute lymphocytic leukemia patients receiving MTX treatment (3- 5 mg/ cm2)

Treatment:

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)

Healthy control group

Description:

20 healthy pediatric subjects not receiving any treatment