Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-12 @ 10:45 AM
Study NCT ID:
NCT01606605
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2012-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Resistance Related With Gene Expression Profile of Diffuse Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Parrafin-embedded tissue blocks'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-12', 'studyFirstSubmitDate': '2012-05-22', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who relapse or progress after 1st line chemotherapy', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'Number and type of genes and microRNA which are significantly related with relapse or progression (P < 0.05)', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Prognosis', 'Relapse', 'Gene', 'microRNA'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The investigators perform a retrospective microarray gene expression profiling study of FFPE from a cohort of DLBCL patients with whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay. The investigators also study the pattern of microRNA from patients with diffuse large B-cell lymphoma. The results of gene expression profiles and microRNA is correlated with clinical outcomes of diffuse large B-cell lymphoma.', 'detailedDescription': '1. Whole genome cDNA mediated Annealing Selection and Ligation (WG-DASL) assay\n\n * Diffuse large B-cell lymphoma patients\n * Paraffin-embedded tissue\n * End points: Progression-free survival, overall survival\n * Statistics: Leave one-out method\n2. Nano string assay for microRNA\n\n * Diffuse large B-cell lymphoma patients\n * Paraffin-embedded tissue\n * End points: Progression-free survival, overall survival\n * Statistics: Leave one-out method'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diffuse large B-cell lymphoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with diffuse large B-cell lymphoma\n* Patients with tissue blocks available for study\n* Patients with adequate medical records\n\nExclusion Criteria:\n\n* Patients diagnosed with other subtypes of lymphoma'}, 'identificationModule': {'nctId': 'NCT01606605', 'briefTitle': 'Treatment Resistance Related With Gene Expression Profile of Diffuse Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Retrospective Analysis of Diffuse Large B-cell Lymphoma: Identification of Factors Associated With Treatment Resistance Via Gene Expression Profile', 'orgStudyIdInfo': {'id': '2010-05-025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diffuse large B-cell lymphoma', 'description': 'Patients diagnosed and treated at the Samsung Medical Center'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Cancer Research Institute', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Seog Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center Cancer Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}