Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-04-13 @ 9:28 PM
Study NCT ID:
NCT02364050
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-02-13', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS', 'timeFrame': '5 years', 'description': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '5 years', 'description': 'Progression free survival'}, {'measure': 'FFS', 'timeFrame': '5 years', 'description': 'Failure Free Survival'}, {'measure': 'Response to initial therapy', 'timeFrame': '5 years'}, {'measure': 'Early mortality rate', 'timeFrame': '5 years'}, {'measure': '% of patients who performed pre-phase therapy', 'timeFrame': '5 years', 'description': 'Come to the prefect Therapy is a steroid-based therapy (administered at dosage of at least 25 mg / day) and / or vincristine, which precedes the beginning of the program of chemoimmunotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymphoma, Large B-Cell, Diffuse']}, 'referencesModule': {'references': [{'pmid': '33577377', 'type': 'DERIVED', 'citation': 'Merli F, Luminari S, Tucci A, Arcari A, Rigacci L, Hawkes E, Chiattone CS, Cavallo F, Cabras G, Alvarez I, Fabbri A, Re A, Puccini B, Barraclough A, Delamain MT, Ferrero S, Usai SV, Ferrari A, Cencini E, Pennese E, Zilioli VR, Marino D, Balzarotti M, Cox MC, Zanni M, Di Rocco A, Lleshi A, Botto B, Hohaus S, Merli M, Sartori R, Gini G, Nassi L, Musuraca G, Tani M, Bottelli C, Kovalchuk S, Re F, Flenghi L, Molinari A, Tarantini G, Chimienti E, Marcheselli L, Mammi C, Spina M. Simplified Geriatric Assessment in Older Patients With Diffuse Large B-Cell Lymphoma: The Prospective Elderly Project of the Fondazione Italiana Linfomi. J Clin Oncol. 2021 Apr 10;39(11):1214-1222. doi: 10.1200/JCO.20.02465. Epub 2021 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G).', 'detailedDescription': 'Prospective data collection of a consecutive series of elderly patients with large B-cell lymphoma newly diagnosed, receiving before the start of treatment Multidimensional Geriatric Assessment (VGM) through the use of Activity of Daily Living (ADL), Instrumental Activity of Daily Living (IADL) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) to be defined in 3 categories:\n\n* elderly FIT (ADL 6; IADL 8; 0 score= 3-4, \\< 5 score=2)\n* elderly UNIFIT (ADL 5; IADL 6-7; 0 score= 3-4, 5-8 score=2; ≥ 80 fit)\n* elderly FRAIL (ADL ≤ 4; IADL ≤ 5; 1 score= 3-4, \\> 8 score=2; ≥ 80 unfit)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Large B-cell Lymphoma\n* Age ≥ 65 years\n* informed Consent\n\nExclusion Criteria:\n\n* Violation of inclusion criteria\n* Abscence of data considered essential for the study\n* Withdrawal of Consent'}, 'identificationModule': {'nctId': 'NCT02364050', 'briefTitle': 'Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'Prospective Data Collection of Elderly Patients (≥ 65 Years) With Diffuse Large B-cell Lymphoma (DLBCL) Receiving at the Time of Diagnosis Multidimensional Geriatric Assessment (VGM)', 'orgStudyIdInfo': {'id': 'FIL_Elderly Project'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly patients with DLBCL', 'description': 'Elderly patients (Age ≥ 65 years) with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Treviglio', 'state': 'Bergamo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Caravaggio', 'geoPoint': {'lat': 45.52081, 'lon': 9.59102}}, {'city': 'Tricase', 'state': 'LE', 'country': 'Italy', 'facility': 'A.O.Cardinale Panico Ematologia e centro trapianti', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'IRCCS Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'country': 'Italy', 'facility': 'CRO-Centro di Riferimento Oncologico', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '85028', 'city': 'Rionero in Vulture', 'state': 'Potenza', 'country': 'Italy', 'facility': 'CROB', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'zip': '04100', 'city': 'Latina', 'state': 'Roma', 'country': 'Italy', 'facility': 'Polo Pontino', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '10015', 'city': 'Ivrea', 'state': 'Torino', 'country': 'Italy', 'facility': 'ASL TO-4', 'geoPoint': {'lat': 45.46723, 'lon': 7.87617}}, {'zip': '31033', 'city': 'Castelfranco Veneto', 'state': 'Treviso', 'country': 'Italy', 'facility': 'Ospedale S. 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Andrea', 'geoPoint': {'lat': 45.32163, 'lon': 8.41989}}], 'overallOfficials': [{'name': 'Michele Spina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRO-Centro di Riferimento Oncologico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}