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This study aims to:
It is a prospective observational study will be carried out on children receiving high dose methotrexate in Sohag Oncology Centre with one-year observation starting from January 2024.
All children receiving high dose methotrexate in Sohag Oncology Centre and fulfill the study inclusion criteria with one-year observation starting from January 2024. Informed consent will be taken from the parents/guardians.
A Prepared sheet to collect data related to this study that include:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood methotrexate level and Cystatin C level | Diagnostic Test | blood methotrexate level and Cystatin C level |
| Measure | Description | Time Frame |
|---|---|---|
| Role of methotrexate blood level in prediction of methotrexate related toxicities | Venous blood will be collected under complete aseptic condition about 5 milliliters to measure serum methotrexate level using drug analyzer then the level of methotrexate will be used as apredictor to identify high dose methotrexate related toxicities in pediatric malignancies We will see if the test could predict the occurrence of toxicities before it happens or not | baseline |
| Role of Cystatin C in prediction of acute kidney injury | Venous samples will be collected about 3 milliliters under complete aseptic condition then centrifuged then the level of Cystatin C will be measured and will be used as abiomarker to detect acute kidney injury associated with high dose methotrexate related toxicities We will see if the test could predict occurrence of acute kidney injury before it happens or not | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Children admitted to Sohag Oncology Centre, age from 1 to 18 years and receive high dose methotrexate therapy equal to or more than 1 gm/m2 surface area.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hosam H Khalaf, Doctor | Contact | +201142361757 | hossamhassan@med.sohag.edu.eg | |
| Mai M Abd Elkader, lecturer | Contact | +201005669072 |
| Name | Affiliation | Role |
|---|---|---|
| Maha A Helal, Professor | Sohag University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29780646 | Background | Barreto JN, McClanahan AL, Rule AD, Thompson CA, Frazee E. Incorporating Cystatin C to Predict Methotrexate Elimination in Patients with CNS Lymphoma and Suspicious Renal Function. Case Rep Hematol. 2018 Mar 26;2018:7169897. doi: 10.1155/2018/7169897. eCollection 2018. | |
| 24829573 | Background | Bebarta VS, Hensley MD, Borys DJ. Acute methotrexate ingestions in adults: a report of serious clinical effects and treatments. J Toxicol. 2014;2014:214574. doi: 10.1155/2014/214574. Epub 2014 Apr 16. |
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| 28435338 | Background | Bello AE, Perkins EL, Jay R, Efthimiou P. Recommendations for optimizing methotrexate treatment for patients with rheumatoid arthritis. Open Access Rheumatol. 2017 Mar 31;9:67-79. doi: 10.2147/OARRR.S131668. eCollection 2017. |
| 31308758 | Background | Li X, Sui Z, Jing F, Xu W, Li X, Guo Q, Sun S, Bi X. Identifying risk factors for high-dose methotrexate-induced toxicities in children with acute lymphoblastic leukemia. Cancer Manag Res. 2019 Jul 5;11:6265-6274. doi: 10.2147/CMAR.S207959. eCollection 2019. |