Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-29 @ 10:58 AM
Study NCT ID:
NCT00898066
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2009-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0334 Analyzing Chromosomes in Patients With Newly Diagnosed Multiple Myeloma or Other Blood Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D008998', 'term': 'Monoclonal Gammopathy of Undetermined Significance'}, {'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D017404', 'term': 'In Situ Hybridization, Fluorescence'}], 'ancestors': [{'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics', 'timeFrame': '1 year'}, {'measure': 'Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival', 'timeFrame': '1 year'}, {'measure': 'Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors', 'timeFrame': '1 year'}, {'measure': 'Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Waldenstrom macroglobulinemia', 'monoclonal gammopathy of undetermined significance', 'primary systemic amyloidosis', 'stage I multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma'], 'conditions': ['Lymphoma', 'Multiple Myeloma and Plasma Cell Neoplasm', 'Precancerous/Nonmalignant Condition']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying the chromosomes in samples of bone marrow and blood in the laboratory from patients with cancer or other blood diseases may help doctors learn more about the disease.\n\nPURPOSE: This laboratory study is analyzing chromosomes in patients with newly diagnosed multiple myeloma or other blood disease.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics in patients with newly diagnosed multiple myeloma (MM) or other monoclonal gammopathies (MG).\n* Examine the prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival in these patients.\n* Compare the prognostic value of cytogenetics and FISH with other MM and MG prognostic factors in these patients.\n* Correlate the presence of cytogenetic and FISH features with clinical pathophysiological, cellular, or other molecular characteristics in these patients.\n\nOUTLINE: Patients receive treatment as directed by the treatment clinical trial on which they are registered. Patients undergo bone marrow or blood sample collection periodically for conventional cytogenetic analysis and fluorescence in situ hybridization studies (FISH). Samples are analyzed for deleted 13q/monosomy 13 and chromosomal abnormalities.\n\nPROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pts from S0115, S0232, S0340, S0417 and all new SWOG MM SM, WM, MGUS studies after 9/1/05 before closure', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of 1 of the following:\n\n * Multiple myeloma (MM)\n * Smoldering myeloma\n * Waldenstrom's macroglobulinemia (WM)\n * Monoclonal gammopathy of undetermined significance (MGUS)\n * Amyloidosis (AL)\n* Newly diagnosed disease\n* Must be currently registered, but have not begun therapy, on 1 of the following Southwest Oncology Group (SWOG) treatment clinical trials:\n\n * SWOG-S0115\n * SWOG-S0232\n * SWOG-S0340\n * All new SWOG coordinated MM, smoldering myeloma, WM, MGUS, or AL clinical trials activated on or after the activation date of this research study (SWOG-S0334)\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics"}, 'identificationModule': {'nctId': 'NCT00898066', 'briefTitle': 'S0334 Analyzing Chromosomes in Patients With Newly Diagnosed Multiple Myeloma or Other Blood Disease', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma', 'orgStudyIdInfo': {'id': 'S0334'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'S0334', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cytogenetic analysis', 'type': 'GENETIC', 'description': 'marrow and peripheral blood'}, {'name': 'fluorescence in situ hybridization', 'type': 'GENETIC', 'description': 'marrow and peripheral blood'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Diane L. Persons, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Kansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}