Prospective Data Collection of Elderly Patients With DLBCL Receiving at the Time of Diagnosis VGM
1 other identifier
observational
1,300
1 country
55
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2013
Longer than P75 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 6, 2020
February 1, 2020
4.3 years
February 10, 2015
February 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
OS
Overall survival
5 years
Secondary Outcomes (5)
PFS
5 years
FFS
5 years
Response to initial therapy
5 years
Early mortality rate
5 years
% of patients who performed pre-phase therapy
5 years
Study Arms (1)
Elderly patients with DLBCL
Elderly patients (Age ≥ 65 years) with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)
Eligibility Criteria
Elderly patients with large B-cell lymphoma classified FIT or UNFIT or FRAIL by Multidimensional Geriatric Assessment (MGA)
You may qualify if:
- Patient with Large B-cell Lymphoma
- Age ≥ 65 years
- informed Consent
You may not qualify if:
- Abscence of data considered essential for the study
- Withdrawal of Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Azienda Ospedaliera Caravaggio
Treviglio, Bergamo, 24127, Italy
A.O.Cardinale Panico Ematologia e centro trapianti
Tricase, LE, Italy
IRCCS Humanitas
Rozzano, Milano, 20089, Italy
CRO-Centro di Riferimento Oncologico
Aviano, Pordenone, 33081, Italy
CROB
Rionero in Vulture, Potenza, 85028, Italy
Polo Pontino
Latina, Roma, 04100, Italy
ASL TO-4
Ivrea, Torino, 10015, Italy
Ospedale S. Giacomo di Castelfranco Veneto
Castelfranco Veneto, Treviso, 31033, Italy
AO SS.Antonio e Biagio
Alessandria, 15121, Italy
AOU Ospedali Riuniti
Ancona, 60126, Italy
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, 70124, Italy
IRCC Istituto tumori Ematologia
Bari, Italy
AO Barletta
Barletta, 76121, Italy
SOS Ematologia Divisione Medicina Interna Ospedale degli Infermi
Biella, Italy
Spedali Civili di Brescia
Brescia, 25123, Italy
Ospedale Businco
Cagliari, 09121, Italy
Arnas Garibaldi
Catania, Italy
AO di Cosenza
Cosenza, Italy
AO Santa Croce e Carle
Cuneo, 12100, Italy
AOU Careggi
Florence, 50134, Italy
Ematologia Ospedale Vito Fazzi
Lecce, Italy
USL 6 Livorno Centro Aziendale Ematologia
Livorno, 57124, Italy
Ospedale di Matera
Matera, 75100, Italy
Area Vasta Romagna e IRST
Meldola (FC), Italy
Ospedali Riuniti Papardo
Messina, 98158, Italy
Fondazione IRCCS Ca' Granda- Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale S. Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
AO Niguarda
Milan, 20162, Italy
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milan, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
Ospedale San Gerardo
Monza, Italy
AUO Maggiore della Carità
Novara, 28100, Italy
Istituto Oncologico Veneto
Padua, 35128, Italy
AOU Padova
Padua, Italy
A.O. Universitaria Policlinico Giaccone Di Palermo
Palermo, 90127, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126, Italy
Fondazione IRCCS Policlinico S.Matteo
Pavia, 27100, Italy
AO di Perugia S. Maria della misericordia
Perugia, 06132, Italy
Ospedale di Pescara
Pescara, 65124, Italy
Ospedale Civile di Piacenza
Piacenza, 29121, Italy
Ospedale S. Maria delle Croci
Ravenna, Italy
A.O. Bianchi Melacrino Morelli
Reggio Calabria, Italy
AO Santa Maria Nuova
Reggio Emilia, 42123, Italy
Ospedale degli Infermi
Rimini, 47923, Italy
AOU La Sapienza
Roma, 00161, Italy
Policlinico Universitario A.Gemelli
Roma, 00168, Italy
Azienda OSpedaliera S. Andrea
Roma, 00189, Italy
AOU Senese
Siena, 53100, Italy
AO Santa Maria di Terni
Terni, 05100, Italy
AO Città della Salute e della Scienza Ematologia Universitaria
Torino, 10126, Italy
AO Città della Salute e della Scienza SC Ematologia
Torino, 10126, Italy
Ospedale di Circolo
Varese, Italy
Presidio Ospedaliero S. Andrea
Vercelli, 13100, Italy
Related Publications (1)
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.
PMID: 33577377DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Spina, MD
CRO-Centro di Riferimento Oncologico
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 16, 2015
Study Start
September 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2020
Last Updated
February 6, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share