Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT01145469
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2010-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy
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': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of single SNP genotype with overall and progression-free survival', 'timeFrame': '1 month'}]}, 'conditionsModule': {'keywords': ['stage I chronic lymphocytic leukemia', 'stage II chronic lymphocytic leukemia', 'stage III chronic lymphocytic leukemia', 'stage IV chronic lymphocytic leukemia', 'B-cell chronic lymphocytic leukemia'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of DNA in the laboratory from patients who received fludarabine-based treatment may help doctors learn more about the effects of fludarabine on cells. It may also help doctors understand how well patients respond to treatment.\n\nPURPOSE: This research study is studying DNA samples from patients with chronic lymphocytic leukemia previously treated with fludarabine-based therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* To identify genetic characteristics associated with the efficacy and toxicity of fludarabine-based treatment in patients with chronic lymphocytic leukemia who participated on E2997.\n* To validate these genetic characteristics with a cancer cell model system to confirm association and dissect the mechanism of effect.\n\nOUTLINE: Archived DNA samples are analyzed for genetic characteristics associated with the efficacy and toxicity to fludarabine-based treatment using Affymetrix 6.0 single nucleotide polymorphism arrays. The results are then compared with data of genes identified in a cancer cell model system, and with clinical data (response, toxicity, overall survival, and progression-free survival) associated with each patient sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples from patients enrolled on E4402 from whom samples were submitted for research', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic lymphocytic leukemia\n* Archived DNA samples\n* Received fludarabine with versus without cyclophosphamide on clinical trial E2997\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT01145469', 'briefTitle': 'Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Genome Wide Association Study Evaluating Genetic Factors Related to the Efficacy and Tolerability of Fludarabine Treatment in Patients With CLL', 'orgStudyIdInfo': {'id': 'CDR0000674957'}, 'secondaryIdInfos': [{'id': 'ECOG-E2997T2'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'polymorphism analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'medical chart review', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tait D. Shanafelt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}