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Comparative Quantification of MTX and Its Metabolites Post Glucarpidase

NCT05250869 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2024-07-22

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

HPLC/MS

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2022-08-31
Completion
2022-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250869 on ClinicalTrials.gov