Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT01478269
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2011-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1927}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aggressive B-cell lymphoma', 'R-CHOP'], 'conditions': ['B-Cell Lymphomas']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective analysis of an homogeneous population of patients with aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed newly diagnosed aggressive B-cell lymphoma according to the current World Health Organisation Classification, from 2001 to 2007.\n2. Any stage of disease.\n3. Treatment with R-CHOP or R-CHOP like regimens (+/- transplant).\n4. Age at least 18 years.\n5. Availability of tissue biopsy at diagnosis for a possible centralized revision.\n6. Availability of data on clinical involvement, laboratory, treatment and follow up.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01478269', 'acronym': 'ProDLBCL', 'briefTitle': 'Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen (ProDLBCL)', 'orgStudyIdInfo': {'id': 'IIL_ProDLBCL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases of aggressive B-cell lymphoma', 'description': 'Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'country': 'Brazil', 'facility': 'Hemocentro-Unicamp', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'city': 'Santa Isabel', 'country': 'Brazil', 'facility': 'Centro Medico', 'geoPoint': {'lat': -23.31556, 'lon': -46.22139}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro Paulista de Oncologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Santa Casa Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '50134', 'city': 'Florence', 'state': 'Firenze', 'country': 'Italy', 'facility': 'Clinica Ematologica Policlinico Carreggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'state': 'Milano', 'country': 'Italy', 'facility': 'Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Alessandria', 'country': 'Italy', 'facility': 'A.O.SS. Biagio, Antonio e Cesare Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Aviano (Pordenone)', 'country': 'Italy', 'facility': 'Centro di riferimento Oncologico Oncologia Medica A', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'USC Ematologia e Trapianto di Midollo Osseo Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Brindisi', 'country': 'Italy', 'facility': 'Presidio Ospedaliero A.Perrino - Divisione di Ematologia', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'city': 'Busto Arsizio', 'country': 'Italy', 'facility': 'U.O. di Oncologia Ospedale di Circolo di Busto Arsizio', 'geoPoint': {'lat': 45.61128, 'lon': 8.84914}}, {'city': 'Camposanpiero (PD)', 'country': 'Italy', 'facility': 'Ospedale Civile'}, {'city': 'Catanzaro', 'country': 'Italy', 'facility': 'A.O.Pugliese Ciaccio Diviisone di Ematologia', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Cosenza', 'country': 'Italy', 'facility': 'Presidio Ospedaliero Annunziata U.O.C. di Ematologia', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Ematologia 1 Ospedale S. 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Ematologia', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'A.O. di Padova Divisione di Oncologia Medica', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Palermo', 'country': 'Italy', 'facility': "Casa di cura La Maddalena Unita' di Ematologia", 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Div. di Ematologia e TMO AOU Policlinico Giaccone di Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Parma', 'country': 'Italy', 'facility': 'A O Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Piacenza', 'country': 'Italy', 'facility': 'Ospedale Civile G.da Saliceto - UOA Ematologia', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Pisana U.O. Ematologia', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'AO Bianchi Melacrino Morelli UO Ematologia', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'AO Arcispedale S.Maria Nuova Ematologia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Rionero in Vulture (PZ)', 'country': 'Italy', 'facility': 'Ospedale Oncologico regionale CROB', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico A. Gemelli Università Cattolica del Sacro Cuore', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano (MI)', 'country': 'Italy', 'facility': 'Clinica Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'A.O.San Giovanni Battista', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Vittorio Veneto', 'country': 'Italy', 'facility': 'U.O. Oncologia Azienda ULSS7 P.O. di Vittorio Veneto', 'geoPoint': {'lat': 45.98026, 'lon': 12.30065}}], 'overallOfficials': [{'name': 'Massimo Federico, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oncologia II Azienda Ospedaliera Universitaria di Modena'}, {'name': 'Stefano Luminari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oncologia II Azienda Ospedaliera Universitaria di Modena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}