Evaluation of High Dose Methotrexate Toxicity

S

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: 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.

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

  • 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

Trial contacts and locations

0

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Central trial contact

Hosam H Khalaf, Doctor; Mai M Abd Elkader, lecturer

Data sourced from clinicaltrials.gov

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