Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-04-13 @ 6:45 PM
Study NCT ID:
NCT01057095
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2010-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Gene Expression in Tissue 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'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of high relative expression levels of PLAGL2 and putative PLAGL2 target genes with potential pathogenic relevance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with del(5q)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia in remission', 'recurrent adult acute myeloid leukemia', 'untreated adult acute myeloid leukemia', 'childhood acute myeloid leukemia in remission', 'recurrent childhood acute myeloid leukemia', 'untreated childhood acute myeloid leukemia and 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 changes that occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This research study is looking at gene expression in tissue samples from patients with acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Screen acute myeloid leukemia (AML) samples to correlate high relative expression levels of PLAGL2 and putative PLAGL2 target genes (implicated in microarray study) with potential pathogenic relevance with respect to AML development.\n\nOUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosis of acute myeloid leukemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of acute myeloid leukemia, including inv(16)(p13;q22) abnormalities\n\n * No t(15;17)(q22;q12) or t(8;21)(q22;q22) abnormalities\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01057095', 'briefTitle': 'Studying Gene Expression in Tissue Samples From Patients With Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Mechanisms of PLAGL2-Induced Leukaemogenesis', 'orgStudyIdInfo': {'id': 'AAML10B12'}, 'secondaryIdInfos': [{'id': 'COG-AAML10B12', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000664240', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'NCI-2011-02208', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'RNA analysis', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Soheil Meshinchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}