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Completed

NCT Number: NCT05021159

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

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Pharmacy, Tanta University, Tanta, Gharbia Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other

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

Primary outcomes

  1. P-gp expression in blood samples

    Time frame: 42 hours

    P-gp expression in blood samples

  2. Methotrexate concentration in blood samples

    Time frame: 42 hours

    Methotrexate concentration in blood samples

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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