Comparative Quantification of MTX and Its Metabolites Post Glucarpidase
1 other identifier
observational
4
1 country
1
Brief Summary
Acidification (i.e., addition of hydrochloric acid) of plasma samples from patients who have received Glucarpidase post high-dose MTX treatment is regarded as a necessary preanalytic step to avoid further in vitro enzymatic cleavage of MTX. However, it is unclear whether this acidification step is essential. A comparative study, which evaluates concentrations of MTX and its metabolites in paired (acidified versus non-acidified) plasma samples, has not yet been performed. Processing plasma samples without acidification would facilitate quantification of MTX, including plasma samples from patients treated at centers without adequate laboratory facilities.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Jul 2022
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
July 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 22, 2024
July 1, 2024
2 months
February 11, 2022
July 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Consistency of MTX concentrations in paired acidified vs. non-acidified samples
Comparison of MTX/metabolite concentrations
within 3 days of Glucarpidase treatment
Secondary Outcomes (1)
Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature
within 3 days of Glucarpidase treatment
Interventions
Quantification of MTX and its metabolites by HPLC/MS under various preanalytical conditions
Eligibility Criteria
Patients treated with high-dose Methotrexate and Glucarpidase
You may qualify if:
- Treatment with Glucarpidase
You may not qualify if:
- Lacking patient consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité - Universitätsmedizin Berlin
Berlin, 12200, Germany
Related Publications (1)
Knornschild FL, Liebig S, Kiessling P, Prpic M, Kim T, Keller U, Kappert K, Schwartz S, Jahic A. Simplified preanalytical laboratory procedures for therapeutic drug monitoring (TDM) in patients treated with high-dose methotrexate (HD-MTX) and glucarpidase. Clin Chem Lab Med. 2024 Jul 15;63(1):e11-e15. doi: 10.1515/cclm-2024-0523. Print 2025 Jan 29. No abstract available.
PMID: 38997789RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. Stefan Schwartz
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 22, 2022
Study Start
July 6, 2022
Primary Completion
August 31, 2022
Study Completion
December 31, 2022
Last Updated
July 22, 2024
Record last verified: 2024-07