Comparative Quantification of MTX and Its Metabolites Post Glucarpidase

February 7, 2023 updated by: Stefan Schwartz, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

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

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charité - Universitätsmedizin Berlin

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with high-dose Methotrexate and Glucarpidase

Description

Inclusion Criteria:

  • Treatment with Glucarpidase

Exclusion Criteria:

  • Lacking patient consent

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 3 days of Glucarpidase treatment

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

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 (ACTUAL)

July 6, 2022

Primary Completion (ACTUAL)

August 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (ACTUAL)

February 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/258/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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