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

NCT ID: NCT05021159

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-08-01

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.

Conditions

Acute Lymphocytic Leukemia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Methotrexate Group

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

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)

Intervention Type: 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

Healthy control group

20 healthy pediatric subjects not receiving any treatment

No interventions assigned to this group

Interventions

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)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Yasmine Elmorsi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasmine M Elmorsi, Msc

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University

Osama M Ibrahim, Professor

Role: STUDY_CHAIR

Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University

Tarek M Mostafa, Professor

Role: STUDY_CHAIR

Assistant Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University

Locations

Faculty of Pharmacy, Tanta University

Tanta, Gharbia Governorate, Egypt

Tanta Cancer Center

Tanta, Gharbia Governorate, Egypt

Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

References

Aller SG, Yu J, Ward A, Weng Y, Chittaboina S, Zhuo R, Harrell PM, Trinh YT, Zhang Q, Urbatsch IL, Chang G. Structure of P-glycoprotein reveals a molecular basis for poly-specific drug binding. Science. 2009 Mar 27;323(5922):1718-22. doi: 10.1126/science.1168750.

Reference Type: BACKGROUND

PMID: 19325113 (View on PubMed)

Namanja HA, Emmert D, Davis DA, Campos C, Miller DS, Hrycyna CA, Chmielewski J. Toward eradicating HIV reservoirs in the brain: inhibiting P-glycoprotein at the blood-brain barrier with prodrug abacavir dimers. J Am Chem Soc. 2012 Feb 15;134(6):2976-80. doi: 10.1021/ja206867t. Epub 2011 Sep 9.

Reference Type: BACKGROUND

PMID: 21866921 (View on PubMed)

Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. doi: 10.1056/NEJMra035092. No abstract available.

Reference Type: RESULT

PMID: 13679531 (View on PubMed)

Other Identifiers

141052

Identifier Type: -

Identifier Source: org_study_id