Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT04205734
Status:
SUSPENDED
Last Update Posted:
2023-10-10
First Post:
2019-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '5 ml of whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID Restrictions', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-08', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methotrexate Polyglutamate Level', 'timeFrame': 'Samples will collected within 16 weeks of consent.', 'description': 'Measurement of Methotrexate Polyglutamate Levels'}], 'secondaryOutcomes': [{'measure': 'The correlation between Methotrexate Polyglutamate Levels and Lab Parameters', 'timeFrame': 'Samples will collected within 16 weeks of consent.', 'description': 'Compare the relationship between Methotrexate Polyglutamage levels and ESR,CRP, Hemoglobin, and Albumin'}, {'measure': 'The correlation between Methotrexate Polyglutamate Levels and Clinical History', 'timeFrame': 'Samples will collected within 16 weeks of consent.', 'description': 'Do Methotrexate Polyglutamate Levels Predict Clinical Outcome as Measured by Disease Activity Indices, including PUCAI for ulcerative colitis and PCDAI for patients with Crohn Disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IBD']}, 'descriptionModule': {'briefSummary': 'There are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.', 'detailedDescription': 'This is a cross-sectional study design. Subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. Data related to the diagnosis and interval assessment of enrolled subjects will also be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with IBD being treated with methotrexate (oral or subcutaneous)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBD\n* Methotrexate Therapy\n\nExclusion Criteria:\n\n* Inability to provide relevant samples'}, 'identificationModule': {'nctId': 'NCT04205734', 'briefTitle': 'Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'IRB-P00028947'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MTX Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of Methotrexate Polyglutamate levels.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'PAUL A RUFO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Web', 'investigatorAffiliation': "Boston Children's Hospital"}}}}