Trials / Unknown
UnknownNCT06123403
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Sohag University · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- —
Summary
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.
Detailed description
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: 1. Socio-demographic data: e.g. age, sex, residence in addition to dose of MTX and tumor type. 2. General and systemic manifestations: gastrointestinal manifestations, neurological manifestations, respiratory and hematological manifestations. 3. Investigations: blood samples will be collected for CBC, Urea, Creatinine, ALT, AST, Methotrexate level and Cystatin C. 4. Treatment lines: fluid, folinic acid, alkalinization of urine, blood elements, hemodialysis and colony stimulating factors. 5. Outcome: complete recovery, residual effects, complications or death.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | blood methotrexate level and Cystatin C level | blood methotrexate level and Cystatin C level |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2025-01-01
- Completion
- 2025-06-01
- First posted
- 2023-11-08
- Last updated
- 2023-11-08
Source: ClinicalTrials.gov record NCT06123403. Inclusion in this directory is not an endorsement.