Evaluation of High Dose Methotrexate Toxicity

Sohag University

Status

Not yet enrolling

Conditions

Methotrexate Toxicity

Treatments

Diagnostic Test: blood methotrexate level and Cystatin C level

Study type

Observational

Funder types

Other

Identifiers

NCT06123403

HD- methotrexate toxicity

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment

100 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria