Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-01 @ 3:40 PM
Study NCT ID:
NCT05250869
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2022-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Quantification of MTX and Its Metabolites Post Glucarpidase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2022-02-11', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consistency of MTX concentrations in paired acidified vs. non-acidified samples', 'timeFrame': 'within 3 days of Glucarpidase treatment', 'description': 'Comparison of MTX/metabolite concentrations'}], 'secondaryOutcomes': [{'measure': 'Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature', 'timeFrame': 'within 3 days of Glucarpidase treatment', 'description': 'Comparison of MTX/metabolite concentrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preanalytical Conditions'], 'conditions': ['Lymphoma', 'Acute Lymphatic Leukemia']}, 'referencesModule': {'references': [{'pmid': '38997789', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nA total of 136 samples from patients post Voraxaze across 3 levels of MTX concentrations:\n\n30 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)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with high-dose Methotrexate and Glucarpidase', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment with Glucarpidase\n\nExclusion Criteria:\n\n* Lacking patient consent'}, 'identificationModule': {'nctId': 'NCT05250869', 'briefTitle': 'Comparative Quantification of MTX and Its Metabolites Post Glucarpidase', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Comparative Quantification of MTX and Its Metabolites in Acidified vs. Non-acidified Blood Samples Post Glucarpidase Using HPLC/MS', 'orgStudyIdInfo': {'id': 'EA4/258/21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HPLC/MS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Quantification of MTX and its metabolites by HPLC/MS under various preanalytical conditions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Stefan Schwartz', 'investigatorFullName': 'Stefan Schwartz', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}