Trial Title:
Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma
NCT ID:
NCT05524298
Condition:
Low Grade Non-Hodgkin's Lymphoma, Adult
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Aims of this study are to describe the variation of QoL (Quality of Life) during the
clinical management of low-grade lymphoma in elderly subjects and to identify the most
important factors at diagnosis and during treatment with an impact on QoL (Quality of
Life).
Detailed description:
This is a prospective, multicenter, non-interventional study aiming at investigating on
the changes in QoL (Quality of Life) during the clinical management of low-grade lymphoma
in elderly subjects and to possibly identify the most important factors at diagnosis and
during treatment with an impact on QoL (Quality of Life).
The study plans to enroll 150 patients with a local histologically confirmed diagnosis of
indolent non-Hodgkin lymphoma fulfilling all the inclusion/exclusion criteria who provide
written informed consent will be included in the study. Any type of treatment is allowed
by the study (immunotherapy, immunochemotherapy at full or reduced dose, radiotherapy).
All patients must undergo Comprehensive Geriatric Assessment (CGA) before starting any
protocol treatment.
Baseline, post-treatment and follow-up instrumental assessments and response evaluation
is done as part of the routine clinical management for patients with indolent NHL (Non
Hodgkin Lymphoma) . Response evaluation and all other assessments planned for the EOT
(end of treatment) should be planned also in case of early withdrawal, according to
clinical practice.
HRQoL (Health-related Quality of Life) evaluation will be done at time of informed
consent form signature prior to treatment start, at the end of the treatment (ranging
from 1 month to 6 months according to the duration of the treatment) and after 1 year
from the start of the therapy.
QoL (quality of life) assessment includes all scales of the EORTC-QLQ-C30 (European
Organisation for Research and Treatment of Cancer Quality of life Questionnaire-Core 30)
and the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma -
lymphoma-specific symptoms questionnaire).
Criteria for eligibility:
Study pop:
Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or
Immunochemotherapy And/Or Radiotherapy.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Local histological diagnosis of indolent B cell non-Hodgkin lymphoma: follicular
lymphoma, marginal zone lymphoma (nodal, MALT (Mucosa-Associated Lymphoid Tissue),
splenic), lymphoplasmacytic lymphoma/ Waldenström macroglobulinemia)
- Age ≥ 70 years
- Patient candidates to receive treatment for lymphoma
- Patient previously untreated for lymphoma
- Evaluation of Comprehensive Geriatric Assessment at baseline
- Ability to provide informed consent: subject understands and voluntarily signs an
informed consent form approved by an IEC (Independent Ethics Committee), prior to
registration into the study
Note: Patient treated in the context of a clinical trial is admitted
Exclusion Criteria:
- none
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
Address:
City:
Alessandria
Zip:
15121
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Manuela Zanni, MD
Email:
manuela.zanni@ospedale.al.it
Investigator:
Last name:
Manuela Zanni
Email:
Principal Investigator
Facility:
Name:
Clinica di Ematologia - A.O.U. Ospedali Riuniti
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Guido Gini, MD
Email:
guido.gini@ospedaliriuniti.marche.it
Investigator:
Last name:
Gini Guido
Email:
Principal Investigator
Facility:
Name:
Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Spina, MD
Email:
mspina@cro.it
Investigator:
Last name:
Michele Spina
Email:
Principal Investigator
Facility:
Name:
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carla Minoia, MD
Email:
carlaminoia@libero.it
Investigator:
Last name:
Carla Minoia
Email:
Principal Investigator
Facility:
Name:
Ematologia - ASST Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandra Tucci, MD
Email:
alessandra.tucci@asst-spedalicivili.it
Investigator:
Last name:
Alessandra Tucci
Email:
Principal Investigator
Facility:
Name:
Ematologia - Ospedale di Castelfranco Veneto
Address:
City:
Castelfranco Veneto
Zip:
31033
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberto Sartori, MD
Email:
roberto.sartori@iov.veneto.it
Investigator:
Last name:
Roberto Sartori
Email:
Principal Investigator
Facility:
Name:
U.O.C. di Ematologia - Azienda Ospedaliera Universitaria Policlinico - Rodolico S. Marco
Address:
City:
Catania
Zip:
95123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annalisa Chiarenza, MD
Investigator:
Last name:
Annalisa Chiarenza
Email:
Principal Investigator
Facility:
Name:
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
Address:
City:
Firenze
Zip:
50141
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Benedetta Puccini, MD
Email:
puccinib@aou-careggi.toscana.it
Investigator:
Last name:
Benedetta Puccini
Email:
Principal Investigator
Facility:
Name:
S.C. Ematologia - Azienda Ospedali Riuniti Papardo-Piemonte
Address:
City:
Messina
Zip:
98158
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Donato Mannina, MD
Email:
donamanni@gmail.com
Investigator:
Last name:
Donato Mannina
Email:
Principal Investigator
Facility:
Name:
Unitа Linfomi - Dipartimento Oncoematologia, Istituto Scientifico San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrés Ferreri, MD
Email:
andres.ferreri@hsr.it
Investigator:
Last name:
Andrés Ferreri
Email:
Principal Investigator
Facility:
Name:
S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Cristina Muzi, MD
Email:
cristina.muzi@ospedaleniguarda.it
Investigator:
Last name:
Cristina Muzi
Email:
Principal Investigator
Facility:
Name:
Ematologia - A.O.U. Policlinico Giaccone
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Salvatrice Mancuso, MD
Email:
salvatrice.mancuso@unipa.it
Investigator:
Last name:
Salvatrice Mancuso
Email:
Principal Investigator
Facility:
Name:
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Caterina Patti, MD
Email:
k.patti@villasofia.it
Investigator:
Last name:
Caterina Patti
Email:
Principal Investigator
Facility:
Name:
U.O. Ematologia - Ospedale Guglielmo da Saliceto
Address:
City:
Piacenza
Zip:
29121
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annalisa Arcari, MD
Email:
a.arcari@ausl.pc.it
Investigator:
Last name:
Annalisa Arcari
Email:
Principal Investigator
Facility:
Name:
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maria Elena Nizzoli, MD
Email:
mariaelena.nizzoli@ausl.re.it
Investigator:
Last name:
Maria Elena Nizzoli
Email:
Principal Investigator
Facility:
Name:
U.O. di Ematologia - Ospedale degli Infermi di Rimini
Address:
City:
Rimini
Zip:
47923
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Melania Celli, MD
Email:
melania.celli@auslromagna.it
Investigator:
Last name:
Melania Celli
Email:
Principal Investigator
Facility:
Name:
Ematologia,Trapianto cellule staminali, Medicina Trasfusionale e Terapia cellulare -Policlinico Universitario Campus Bio-Medico
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ombretta Annibali, MD
Email:
o.annibali@policlinicocampus.it
Investigator:
Last name:
Ombretta Annibali
Email:
Principal Investigator
Facility:
Name:
U.O.C. Ematologia - A.O.U. Senese
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alberto Fabbri, MD
Email:
fabbri7@unisi.it
Investigator:
Last name:
Alberto Fabbri
Email:
Principal Investigator
Facility:
Name:
U.O.C. Ematologia - Ospedale di Circolo
Address:
City:
Varese
Zip:
21100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Merli, MD
Email:
michele.merli@asst-settelaghi.it
Investigator:
Last name:
Michele Merli
Email:
Principal Investigator
Start date:
December 7, 2022
Completion date:
February 2025
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524298
