Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-28 @ 6:49 AM
Study NCT ID:
NCT01138332
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2010-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Young 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': 'D015153', 'term': 'Blotting, Western'}], 'ancestors': [{'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D015151', 'term': 'Immunoblotting'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlations between levels of pY-Stat3 and levels of upstream cytokine receptors'}, {'measure': 'Association of constitutive and/or increased pY-Stat3 and c-kit genotype'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood acute myeloid leukemia/other myeloid malignancies'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.\n\nPURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.\n* Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.\n\nOUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosis of acute myeloid leukemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of acute myeloid leukemia\n* One of the following karyotypes:\n\n * t(8;21) and WT c-kit\n * t(8;21) and mutant c-kit\n * Normal karyotype\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01138332', 'briefTitle': 'Biomarkers in Young Patients With Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Stat3 Signaling Pathway Aberrancies in Pediatric AML', 'orgStudyIdInfo': {'id': 'AAML10B10'}, 'secondaryIdInfos': [{'id': 'COG-AAML10B10', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000671489', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'NCI-2011-02226', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'western blotting', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michele S. Redell, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Texas Children's Cancer Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}