Clinical trial NCT02364050: Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma, Large B-Cell, Diffuse
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 1300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)

Brief summary: 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).

Detailed description: 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:

* elderly FIT (ADL 6; IADL 8; 0 score= 3-4, \< 5 score=2)
* elderly UNIFIT (ADL 5; IADL 6-7; 0 score= 3-4, 5-8 score=2; ≥ 80 fit)
* elderly FRAIL (ADL ≤ 4; IADL ≤ 5; 1 score= 3-4, \> 8 score=2; ≥ 80 unfit)

Eligibility criteria: Inclusion Criteria:

* Patient with Large B-cell Lymphoma
* Age ≥ 65 years
* informed Consent

Exclusion Criteria:

* Violation of inclusion criteria
* Abscence of data considered essential for the study
* Withdrawal of Consent

Primary outcomes:
measure: OS
timeFrame: 5 years
Secondary outcomes:
measure: PFS
timeFrame: 5 years
measure: FFS
timeFrame: 5 years
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
Other outcomes:
Locations:
city: Treviglio
country: Italy
facility: Azienda Ospedaliera Caravaggio
state: Bergamo
city: Tricase
country: Italy
facility: A.O.Cardinale Panico Ematologia e centro trapianti
state: LE
city: Rozzano
country: Italy
facility: IRCCS Humanitas
state: Milano
city: Aviano
country: Italy
facility: CRO-Centro di Riferimento Oncologico
state: Pordenone
city: Rionero in Vulture
country: Italy
facility: CROB
state: Potenza
city: Latina
country: Italy
facility: Polo Pontino
state: Roma
city: Ivrea
country: Italy
facility: ASL TO-4
state: Torino
city: Castelfranco Veneto
country: Italy
facility: Ospedale S. Giacomo di Castelfranco Veneto
state: Treviso
city: Alessandria
country: Italy
facility: AO SS.Antonio e Biagio
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti
city: Bari
country: Italy
facility: A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
city: Bari
country: Italy
facility: IRCC Istituto tumori Ematologia
city: Barletta
country: Italy
facility: AO Barletta
city: Biella
country: Italy
facility: SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Cagliari
country: Italy
facility: Ospedale Businco
city: Catania
country: Italy
facility: Arnas Garibaldi
city: Cosenza
country: Italy
facility: AO di Cosenza
city: Cuneo
country: Italy
facility: AO Santa Croce e Carle
city: Firenze
country: Italy
facility: AOU Careggi
city: Lecce
country: Italy
facility: Ematologia Ospedale Vito Fazzi
city: Livorno
country: Italy
facility: USL 6 Livorno Centro Aziendale Ematologia
city: Matera
country: Italy
facility: Ospedale di Matera
city: Meldola (FC)
country: Italy
facility: Area Vasta Romagna e IRST
city: Messina
country: Italy
facility: Ospedali Riuniti Papardo
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale S. Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: AO Niguarda
city: Milano
country: Italy
facility: Osp. San Carlo Borromeo Divisione di Oncologia Medica
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Novara
country: Italy
facility: AUO Maggiore della Carità
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Padova
country: Italy
facility: AOU Padova
city: Palermo
country: Italy
facility: A.O. Universitaria Policlinico Giaccone Di Palermo
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti Villa Sofia-Cervello
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S.Matteo
city: Perugia
country: Italy
facility: AO di Perugia S. Maria della misericordia
city: Pescara
country: Italy
facility: Ospedale di Pescara
city: Piacenza
country: Italy
facility: Ospedale Civile di Piacenza
city: Ravenna
country: Italy
facility: Ospedale S. Maria delle Croci
city: Reggio Calabria
country: Italy
facility: A.O. Bianchi Melacrino Morelli
city: Reggio Emilia
country: Italy
facility: AO Santa Maria Nuova
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: AOU La Sapienza
city: Roma
country: Italy
facility: Policlinico Universitario A.Gemelli
city: Roma
country: Italy
facility: Azienda OSpedaliera S. Andrea
city: Siena
country: Italy
facility: AOU Senese
city: Terni
country: Italy
facility: AO Santa Maria di Terni
city: Torino
country: Italy
facility: AO Città della Salute e della Scienza Ematologia Universitaria
city: Torino
country: Italy
facility: AO Città della Salute e della Scienza SC Ematologia
city: Varese
country: Italy
facility: Ospedale di Circolo
city: Vercelli
country: Italy
facility: Presidio Ospedaliero S. Andrea
Study officials:
affiliation: CRO-Centro di Riferimento Oncologico
name: Michele Spina, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.