Clinical trial · Observational
Evaluation of High Dose Methotrexate Toxicity
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to: 1. Evaluation of high dose methotrexate related toxicities among children admitted to Sohag Oncology Centre. 2. Role of methotrexate blood level in prediction of high dose methotrexate related toxicities. 3. Role of Cystatin C as a predictor for acute kidney injury in high dose methotrexate related toxicities. 4. Factors affecting outcome of high dose methotrexate related toxicities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Methotrexate Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood methotrexate level and Cystatin C level | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Role of methotrexate blood level in prediction of methotrexate related toxicities
- timeFrame
- baseline
- description
- 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
- measure
- Role of Cystatin C in prediction of acute kidney injury
- timeFrame
- Baseline
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDBarreto 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. PMID 29780646
- BACKGROUNDBebarta 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. PMID 24829573
- BACKGROUNDBello 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. PMID 28435338
- BACKGROUNDLi 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. PMID 31308758