Comparative Quantification of MTX and Its Metabolites Post Glucarpidase

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.

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Key information

Conditions

Lymphoma Acute Lymphatic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 12200, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Treatment with Glucarpidase

Exclusion criteria

Lacking patient consent

Treatment and study plan

HPLC/MS

Diagnostic Test

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

Primary outcomes

Consistency of MTX concentrations in paired acidified vs. non-acidified samples

Time frame: within 3 days of Glucarpidase treatment

Comparison of MTX/metabolite concentrations

Secondary outcomes

Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature

Time frame: within 3 days of Glucarpidase treatment

Comparison of MTX/metabolite concentrations

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Feb 22, 2022
Registry last updated: Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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