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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate Group | 20 acute lymphocytic leukemia patients receiving MTX treatment (3- 5 mg/ cm2) |
| |
| Healthy control group | 20 healthy pediatric subjects not receiving any treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| P-gp expression in blood samples | P-gp expression in blood samples | 42 hours |
| Methotrexate concentration in blood samples | Methotrexate concentration in blood samples | 42 hours |
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Inclusion Criteria:
Exclusion Criteria:
Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)
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Pediatric Acute Lymphocytic Leukemia Patients aged < 18 years old who are already taking the ALL MTX protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Yasmine M Elmorsi, Msc | Assistant lecturer in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University | Principal Investigator |
| Osama M Ibrahim, Professor | Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University | Study Chair |
| Tarek M Mostafa, Professor | Assistant Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Tanta University | Tanta | Gharbia Governorate | 31111 | Egypt | ||
| Tanta Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19325113 | Background | 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. | |
| 21866921 | Background | 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. |
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|
| Tanta |
| Gharbia Governorate |
| 31111 |
| Egypt |
| Tanta University | Tanta | Gharbia Governorate | 31111 | Egypt |
| 13679531 | Result | 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. |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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