Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01498302
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2011-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Laboratory Test Results of Minimal-Residual Disease in Samples From Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005434', 'term': 'Flow Cytometry'}], 'ancestors': [{'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bone marrow and/or peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2011-12-22', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of concordance in the MRD assay results between laboratories'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood acute myeloid leukemia/other myeloid malignancies'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease will come back in patients diagnosed with acute myeloid leukemia.\n\nPURPOSE: This research trial studies the comparison of laboratory test results for minimal residual disease in samples from patients with acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* To promote harmonization between Cooperative Group Reference Laboratories conducting minimal-residual disease (MRD) evaluation of acute myeloid leukemia by flow cytometry.\n\nOUTLINE: Archived bone marrow and blood samples, distributed to the Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B laboratories, are analyzed for leukemia-associated immunophenotype (LAIP) assays and minimal residual disease studies by flow cytometry. Results are then provided to the National Cancer Institute for assessment and comparability of test results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Acute myeloid leukemia (AML) enrolled on Children's Oncology Group (COG) studies.", 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Non-identified cryopreserved samples of bone marrow and/or peripheral blood from patients with acute myeloid leukemia (AML) from the Children Oncology Group (COG) studies\n\n * Baseline/diagnostic AML samples\n * Samples collected after initial treatment and representing varying levels of residual blast counts\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01498302', 'briefTitle': 'Comparison of Laboratory Test Results of Minimal-Residual Disease in Samples From Patients With Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Interlaboratory Comparability Study of Residual Disease in Acute Myelogenous Leukemia', 'orgStudyIdInfo': {'id': 'AAML12B5'}, 'secondaryIdInfos': [{'id': 'COG-AAML12B5', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AAML12B5', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2012-00098', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'diagnostic laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'flow cytometry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'J. Milburn Jessup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}