Evaluation of High Dose Methotrexate Toxicity

Trial Title: Evaluation of High Dose Methotrexate Toxicity

NCT ID: NCT06123403

Condition: Methotrexate Toxicity

Conditions: Official terms:
Methotrexate
Cystatins

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: blood methotrexate level and Cystatin C level
Description: blood methotrexate level and Cystatin C level

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 1 Year

Maximum age: 18 Years

Start date: January 2024

Completion date: June 2025

Lead sponsor:
Agency: Sohag University
Agency class: Other

Source: Sohag University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06123403