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Not yet recruitingNCT06123403Updated Nov 8, 2023

Evaluation of High Dose Methotrexate Toxicity

An observational study in Methotrexate Toxicity, sponsored by Sohag University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
1 Year to 18 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Methotrexate Toxicity
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • WBCs less than 1000 / microliter
  • Platelet count less than 50000 / microliter
  • Renal affection
  • Hepatic affection
  • Respiratory affection
  • Diabetes mellitus
  • Cardiovascular disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testblood methotrexate level and Cystatin C level

    blood methotrexate level and Cystatin C level

06

What researchers measure

Primary outcomes

  1. Role of methotrexate blood level in prediction of methotrexate related toxicities

    Venous blood will be collected under complete aseptic condition about 5 milliliters to measure serum methotrexate level using drug analyzer then the level of methotrexate will be used as apredictor to identify high dose methotrexate related toxicities in pediatric malignancies We will see if the test could predict the occurrence of toxicities before it happens or not

    Time frame: baseline

  2. Role of Cystatin C in prediction of acute kidney injury

    Venous samples will be collected about 3 milliliters under complete aseptic condition then centrifuged then the level of Cystatin C will be measured and will be used as abiomarker to detect acute kidney injury associated with high dose methotrexate related toxicities We will see if the test could predict occurrence of acute kidney injury before it happens or not

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29780646 ↗
  • 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. PubMed 24829573 ↗
  • 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. PubMed 28435338 ↗
  • 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. PubMed 31308758 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06123403
Lead sponsor
Sohag University
Responsible party
Hosam Hasan Khalaf (assistant lecturer, Sohag University) — Principal investigator
First posted
Nov 8, 2023
Start date
Jan 2024 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Nov 8, 2023

Study contacts

Hosam H Khalaf, Doctor
Contact
hossamhassan@med.sohag.edu.eg
+201142361757
Mai M Abd Elkader, lecturer
Contact
+201005669072
Maha A Helal, Professor
study director · Sohag University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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