Evaluation of High Dose Methotrexate Toxicity

Study Overview
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Brief Summary
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This study aims to: Evaluation of high dose methotrexate related toxicities among children admitted to Sohag Oncology Centre. Role of methotrexate blood level in prediction of high dose methotrexate related toxicities. Role of Cystatin C as a predictor for acute kidney injury in high dose methotrexate related toxicities. Factors affecting outcome of high dose methotrexate related toxicities.

Detailed Description
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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: Socio-demographic data: e.g. age, sex, residence in addition to dose of MTX and tumor type. General and systemic manifestations: gastrointestinal manifestations, neurological manifestations, respiratory and hematological manifestations. Investigations: blood samples will be collected for CBC, Urea, Creatinine, ALT, AST, Methotrexate level and Cystatin C. Treatment lines: fluid, folinic acid, alkalinization of urine, blood elements, hemodialysis and colony stimulating factors. Outcome: complete recovery, residual effects, complications or death.

Official Title
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Evaluation of High Dose Methotrexate Toxicity in Correlation With Blood Methotrexate Level and the Role of Cystatin C in Prediction of Acute Kidney Injury in Pediatric Malignancies

Conditions
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Methotrexate Toxicity

Intervention / Treatment
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* Diagnostic Test: blood methotrexate level and Cystatin C level


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children admitted to Sohag Oncology Centre, age from 1 to 18 years receive high dose methotrexate therapy equal to or more than 1 gm/m2 surface area. Exclusion Criteria: WBCs less than 1000 / microliter Platelet count less than 50000 / microliter Renal affection Hepatic affection Respiratory affection Diabetes mellitus Cardiovascular disease

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: blood methotrexate level and Cystatin C level|blood methotrexate level and Cystatin C level|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |