Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-30 @ 5:45 PM
Study NCT ID:
NCT01005368
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2009-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], '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': 'D015448', 'term': 'Leukemia, B-Cell'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017404', 'term': 'In Situ Hybridization, Fluorescence'}, {'id': 'D001483', 'term': 'Base Sequence'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D015153', 'term': 'Blotting, Western'}, {'id': 'D005434', 'term': 'Flow Cytometry'}], 'ancestors': [{'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D015151', 'term': 'Immunoblotting'}, {'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and bone marrow samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2009-10-29', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response', 'timeFrame': 'Up to 10 years'}, {'measure': 'prolonged progression-free survival', 'timeFrame': 'Up to 10 years'}, {'measure': 'overall survival', 'timeFrame': 'Up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic lymphocytic leukemia'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.\n\nPURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (CR), prolonged progression-free survival (PFS), and overall survival (OS) in patients with previously untreated chronic lymphocytic leukemia.\n* Determine the significance of the absence of IgV\\_H gene mutational status as related to the ability to predict CR, PFS, and OS in these patients.\n* Correlate IgV\\_H gene mutational status with CD38 expression, ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients.\n* Determine the prognostic significance of over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, ATM mutation, ATM expression, and other factors that disrupt apoptosis with respect to CR, prolonged PFS, and OS.\n* Determine if clonal evolution occurs in these biological markers at partial response or disease relapse.\n\nOUTLINE: This is a multicenter study.\n\nBlood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV\\_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with chronic lymphocytic leukemia and were previously untreated. The patients must have also previously enrolled on a Cancer and Leukemia Group B protocol.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic lymphocytic leukemia\n\n * Previously untreated disease\n* Registered to receive treatment on a Cancer and Leukemia Group B protocol\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT01005368', 'briefTitle': 'Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Molecular Markers Of Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'CALGB-20203'}, 'secondaryIdInfos': [{'id': 'CALGB-20203'}, {'id': 'CDR0000398201', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV\\_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.', 'interventionNames': ['Genetic: fluorescence in situ hybridization', 'Genetic: mutation analysis', 'Genetic: nucleic acid sequencing', 'Genetic: polymerase chain reaction', 'Genetic: western blotting', 'Other: flow cytometry', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'fluorescence in situ hybridization', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'mutation analysis', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'nucleic acid sequencing', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'polymerase chain reaction', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'western blotting', 'type': 'GENETIC', 'armGroupLabels': ['Group 1']}, {'name': 'flow cytometry', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Office -Vandever Medical Office', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'facility': 'Tunnell Cancer Center at Beebe Medical Center', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Comprehensive Cancer Center at Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Louis A. Weiss Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46845', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology and Hematology', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '52242-1002', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Holden Comprehensive Cancer Center at University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '04330', 'city': 'Augusta', 'state': 'Maine', 'country': 'United States', 'facility': 'Harold Alfond Center for Cancer Care', 'geoPoint': {'lat': 44.31062, 'lon': -69.77949}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'CancerCare of Maine at Eastern Maine Medical Center', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '20889-5600', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Naval Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '21921', 'city': 'Elkton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Union Hospital of Cecil County', 'geoPoint': {'lat': 39.60678, 'lon': -75.83327}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - 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James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15224-1791', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29501', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'McLeod Regional Medical Center', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}, {'zip': '05602', 'city': 'Berlin Corners', 'state': 'Vermont', 'country': 'United States', 'facility': 'Mountainview Medical', 'geoPoint': {'lat': 44.21006, 'lon': -72.57594}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care - University Health Center Campus', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'John C. Byrd, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}