Methotrexate ToxicityNCT06123403
Evaluation of High Dose Methotrexate Toxicity
An observational study of Methotrexate Toxicity, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Methotrexate Toxicity
- What is being tested?
- blood methotrexate level and Cystatin C level
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- WBCs less than 1000 / microliter
- Platelet count less than 50000 / microliter
- Renal affection
- Hepatic affection
- Respiratory affection
- Diabetes mellitus
- Cardiovascular disease
Trial locations and contacts
No sites are listed yet.
Mai M Abd Elkader, lecturer contact
About this study
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
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.
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:
- 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.
- Conditions
- Methotrexate Toxicity
- Being tested
- blood methotrexate level and Cystatin C level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood methotrexate level and Cystatin C levelDiagnostic test
blood methotrexate level and Cystatin C level
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Methotrexate ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Hasan Khalaf, Sohag University
- Investigators
- Maha A Helal, Professor, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123403
- Sponsor's protocol ID
- HD- methotrexate toxicity
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
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 29780646Bebarta 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 24829573Bello 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 28435338Li 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06123403
- Acronym / sponsor ID
- HD- methotrexate toxicity
- Conditions
- Methotrexate Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- WBCs less than 1000 / microliter
- Platelet count less than 50000 / microliter
- Renal affection
- Hepatic affection
- Respiratory affection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood methotrexate level and Cystatin C levelblood methotrexate level and Cystatin C level | Diagnostic test | – |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 29780646Barreto 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.
- Background: PubMed 24829573Bebarta 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.
- Background: PubMed 28435338Bello 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.
- Background: PubMed 31308758Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai M Abd Elkader, lecturer contact
Maha A Helal, Professor study director
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Methotrexate Toxicity, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hosam H Khalaf, Doctor (+201142361757, hossamhassan@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of methotrexate blood level in prediction of methotrexate related toxicities (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123403, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.