Comparative Quantification of MTX and Its Metabolites Post Glucarpidase

Comparative Quantification of MTX and Its Metabolites in Acidified vs. Non-acidified Blood Samples Post Glucarpidase Using HPLC/MS

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05250869

Enrollment

Registered

2022-02-22

Start date

2022-07-06

Completion date

2022-12-31

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphatic Leukemia, Lymphoma

Keywords

Preanalytical Conditions

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.

Detailed description

Stored plasma samples (paired - acidified and non-acidified) from the specimens collection ('Tumorbiobank') of the Charité Comprehensive Cancer Center will be analysed by HPLC/MS. A total of 136 samples from patients post Voraxaze across 3 levels of MTX concentrations: 30 without additive, 10 with 0.9% NaCl, 30 with HCl (stored at -80C) 9 without additive, 9 with HCl (stored at +4C and analysed after 3-5 days) 9 without additive, 9 with HCl (stored at -20C and analysed after 3-5 days) 30 with HCl (stored at +4C versus ambient temperature)

Interventions

DIAGNOSTIC_TESTHPLC/MS

Quantification of MTX and its metabolites by HPLC/MS under various preanalytical conditions

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Treatment with Glucarpidase

Exclusion criteria

* Lacking patient consent

Design outcomes

Primary

Measure	Time frame	Description
Consistency of MTX concentrations in paired acidified vs. non-acidified samples	within 3 days of Glucarpidase treatment	Comparison of MTX/metabolite concentrations

Secondary

Measure	Time frame	Description
Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature	within 3 days of Glucarpidase treatment	Comparison of MTX/metabolite concentrations

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026