Clinical trial NCT06123403: Evaluation of High Dose Methotrexate Toxicity
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Methotrexate Toxicity
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Role of methotrexate blood level in prediction of methotrexate related toxicities
timeFrame: baseline
measure: Role of Cystatin C in prediction of acute kidney injury
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Maha A Helal, Professor
role: STUDY_DIRECTOR
References:
citation: Barreto 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.
citation: Bebarta 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.
citation: Bello 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.
citation: Li 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.