Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-29 @ 5:45 AM
Study NCT ID:
NCT00899366
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], '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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}], 'ancestors': [{'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'bone marrow and blood nucleic acids and cells.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2009-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptional signatures associated with NOTCH1 mutations in T-cell acute lymphoblastic leukemia (T-ALL) cells', 'timeFrame': '1 month', 'description': 'Mutational analysis'}, {'measure': 'Global changes on gene expression resulting from inactivation of NOTCH signaling in T-ALL cells', 'timeFrame': '1 month', 'description': 'Gene expression'}]}, 'conditionsModule': {'keywords': ['T-cell adult acute lymphoblastic leukemia', 'T-cell childhood acute lymphoblastic leukemia', 'untreated adult acute lymphoblastic leukemia', 'untreated childhood acute lymphoblastic leukemia', 'recurrent adult acute lymphoblastic leukemia', 'recurrent childhood acute lymphoblastic leukemia', 'adult acute lymphoblastic leukemia in remission', 'childhood acute lymphoblastic leukemia in remission'], 'conditions': ['Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2721784/', 'label': 'Manuscript'}]}, '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 laboratory study is looking at tissue samples from patients with T-cell acute lymphoblastic leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Identify the transcriptional signatures associated with the presence of NOTCH1 mutations in primary T-cell acute lymphoblastic leukemia (T-ALL) cells using oligonucleotide microarrays.\n* Characterize the global changes on gene expression resulting from the inactivation of NOTCH signaling in human T-ALL lymphoblasts.\n\nOUTLINE: This is a multicenter study.\n\nFrozen lymphoblast samples from patients with T-cell acute lymphoblastic leukemia (NOTCH1-mutated and wild type) are assessed for genetic expression profiles and mutations by microarray analysis and activated NOTCH1 protein by western blot analysis.\n\nPROJECTED ACCRUAL: A total of 48 samples from patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples submitted for research from patients participating in E2993', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Confirmed diagnosis of T-cell acute lymphoblastic leukemia\n* Frozen lymphoblast samples available\n\n * NOTCH1-mutated or wild type sample available\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT00899366', 'briefTitle': 'DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Molecular Mechanisms of NOTCH Induced Transformation in T-ALL', 'orgStudyIdInfo': {'id': 'CDR0000529758'}, 'secondaryIdInfos': [{'id': 'ECOG-E2993T2', 'type': 'OTHER', 'domain': 'ECOG-ACRIN'}, {'id': 'R01CA129382', 'link': 'https://reporter.nih.gov/quickSearch/R01CA129382', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'microarray analysis', 'type': 'GENETIC'}, {'name': 'mutation analysis', 'type': 'GENETIC'}, {'name': 'immunologic technique', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Adolfo A. Ferrando, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ECOG-ACRIN Cancer Research Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}