Evaluation of High Dose Methotrexate Toxicity

November 7, 2023 updated by: Hosam Hasan Khalaf, Sohag University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mai M Abd Elkader, lecturer
  • Phone Number: +201005669072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of methotrexate blood level in prediction of methotrexate related toxicities
Time Frame: baseline
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
baseline
Role of Cystatin C in prediction of acute kidney injury
Time Frame: Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Maha A Helal, Professor, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Estimated)

November 8, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD- methotrexate toxicity

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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