This is a retrospective/prospective, cohort, non-interventional observational study. This means that all patients with documented COVID and HM diagnosed between February 2020 and study initiation will compose the retrospective part, while those diagnosed after study approval will enter prospective part. The total duration of the study will be 12 months. The study population will must be older than 18 years of age with HM and SARS-CoV-2 infection. All patients with documented SARS-CoV-2 infection (COVID) and history or active hematological malignancies, who refer to any Hematological Unit will be included.
This is a retrospective/prospective, cohort, non-interventional observational study. An
informed consensus for the participation is available. In this section we provide
informations on sample size and statistical analysis.
In Italy, the projected estimate of complete HM prevalence at Jan 1, 2020 has been
established as 48,254 cases for Hodgkin lymphoma, 110.715 cases for non Hodgkin Lymphomas,
67,301 for leukemias, and 25,066 for multiple myeloma (Guzzinati et al, BMC Cancer 2018). The
Italian Dipartimento della Protezione Civile website reported (March 23, 2020) that 63,927
cases are currently infected with SARS-CoV-2. No formal sample size calculation was made for
this project but, on the basis of data available to date, considering the prevalence of
hematological patients in Italy (0.4%) and assuming that these patients have the same risk of
contracting COVID-19 as the general population, we supposed to enroll at least 250 patients
(at March 24, 2020).
Statistical analyses All data collected will be summarized using appropriate descriptive
statistics: absolute and relative frequencies for discrete variables; mean, standard
deviation, median and interquartile range for continuous ones. To identify factors
significantly associated with composite endpoint, log-binomial regression will be used for
modelling risk ratio together with 95% confidence interval estimated.
The least absolute shrinkage and selection operator (LASSO) method will be applied for
selecting the factors able to independently predict primary end-point. LASSO selects
variables correlates to the measured outcome by shrinking coefficients weights, down to zero
for the ones not correlated to outcome. In addition, machine learning techniques will be used
for validating results from LASSO. A weight will be assigned to each coefficient of the
selected predictors and weights will be summed to produce a total aggregate score. Predictive
performance will be assessed through discrimination and calibration. Discrimination indicates
how well the model can distinguish individuals with the outcome from those without the
outcome. Two, the net reclassification improvement (NRI) will be calculated for assessing the
'net' number of individuals correctly reclassified using "the new model" over a comparator
index [i.e., CCI (Charlson Comorbidity Score) or MCS (Multisource Comorbidity Score), or
HM-disease specific]. Calibration ascertains the concordance between the model's predictions
and observed outcomes, which we evaluated using a calibration plot. Cartographic and
geostatistical methods will be used to exploring the spatial patterns of disease. An
Exploratory Spatial Data Analysis (ESDA) and the Kriging method will be also applied to
describe and model spatial (geographical) pattern.
Inclusion Criteria:
- Age equal to or greater than 18 years of age.
- History of hematological malignancies (acute leukemias, myelodysplastic syndromes,
myeloproliferative neoplasms, lymphomas, myeloma).
- Active hematological malignancies (acute leukemias, myelodysplastic syndromes,
myeloproliferative neoplasms, lymphomas, myeloma) at any stage/status.
- SARS-CoV-2 positive test (nasopharyngeal, BAL, fecal), documented by Real-Time Reverse
Transcriptase (RT)-PCR Diagnostic Panels.
Exclusion Criteria:
- Hematological diseases, other than hematological malignancies.
- SARS-CoV-2 negative test.
SC Ematologia Ospedale SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
UOC Ematologia, Ospedali Riuniti
Ancona, Italy
UOC Ematologia e Terapia Cellulare, Ospedale Mazzoni
Ascoli Piceno, Italy
SC Oncologia Medica, CRO
Aviano, Italy
SC Ematologia, Policlinico Bari
Bari, Italy
UOC Ematologia, I.R.C.C.S Istituto Tumori Giovanni Paolo II
Bari, Italy
SSD Ematologia, Ospedale degli Infermi
Biella, Italy
UOC Ematologia, Azienda Ospedaliero-Universitaria Policlinico S.Orsola-Malpighi,
Bologna, Italy
Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano
Bolzano, Italy
UO Ematologia e CTMO, ASST Spedali Civili
Brescia, Italy
UO Ematologia e CTMO, ASST Spedali Civili
Brescia, Italy
UOC Onco-Ematologia ASST Valle Olona
Busto Arsizio, Italy
SC Ematologia e CTMO AZIENDA OSPEDALIERA "G. BROTZU" - OSPEDALE ONCOLOGICO BUSINCO
Cagliari, Italy
UOC Ematologia, AOU Policlinico Vittorio Emanuele
Catania, Italy
Ematologia, Ospedale Valduce
Como, Italy
UOC Ematologia, Azienda Ospedaliera di Cosenza
Cosenza, Italy
UO Ematologia e CTMO, ASST Cremona
Cremona, Italy
SC Ematologia Ospedale S. Croce
Cuneo, Italy
UOC, Ematologia Azienda Ospedaliero Universitaria Arcispedale S. Anna
Ferrara, Italy
S.O.D. Ematologia, Azienda Ospedaliero Universitaria Careggi
Firenze, Italy
UOC Ematologia, Policlinico Ospedali Riuniti
Foggia, Italy
IRST-IRCC di Meldola
Forlì, Italy
UO Ematologia, Ospedale Policlinico S.Martino IRCCS
Genova, Italy
UO Ematologia, Ospedale Policlinico San Martino
Genova, Italy
UOC di Ematologia e Trapianto di Cellule Staminali, P.O. Vito Fazzi
Lecce, Italy
UOC di Ematologia, Ospedale di Legnano
Legnano, Italy
UO Dipartimento di Ematologia, USL 6
Livorno, Italy
UOC Oncologia ASST Lodi
Lodi, Italy
UOC Ematologia Azienda Ospedaliera Universitaria "G.Martino"
Messina, Italy
UO Ematologia, Ospedale dell'Angelo di Mestre
Mestre, Italy
Ematologia, IEO
Milano, Italy
SC Ematologia, Istituto Nazionale dei Tumori
Milano, Italy
SC Ematologia, Ospedale Niguarda
Milano, Italy
UO Ematologia, IRCCS Ospedale San Raffaele
Milano, Italy
UO Servizio di Ematologia e Medicina Trasfusionale, Ospedale Luigi Sacco
Milano, Italy
UOC Ematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
UO Ematologia Policlinico di Modena
Modena, Italy
UOC Ematologia, Ospedale S. Gerardo
Monza, Italy
SC Ematologia Istituto Nazionale Tumori - IRCCS "Fondazione G. Pascale",
Napoli, Italy
UOC Ematologia e Trapianti di Midollo, AOU Federico II
Napoli, Italy
UOC Ematologia, Ospedale Antonio Cardarelli
Napoli, Italy
UOC Ematologia, Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara, Italy
Ospedale san Luigi Gonzaga
Orbassano, Italy
Ematologia Azienda Ospedaliera di Padova
Padova, Italy
UO Ematologia, Policlinico Paolo Giaccone
Palermo, Italy
UOC Ematologia e CTMO, Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
SC Ematologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
SC Ematologia e Trapianto di Midollo Osseo, Azienda Ospedaliera di Perugia
Perugia, Italy
UO Ematologia e CTMO, Azienda Ospedaliera Ospedali Riuniti
Pesaro, Italy
UOC di Ematologia, Ospedale Civile Spirito Santo
Pescara, Italy
UO Ematologia e CTMO, Presidio Ospedaliero di Piacenza
Piacenza, Italy
UO Ematologia, AOU Pisana- Santa Chiara
Pisa, Italy
UO Ematologia dell'Ospedale Santa Maria delle Croci
Ravenna, Italy
UOC Ematologia, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
SC Ematologia, Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
UO Ematologia, Ospedale Infermi
Rimini, Italy
AOU Azienda Ospedaliera Universitaria Sant'Andrea
Roma, Italy
IFO - Ematologia e Trapianto Cellule -Istituto Nazionale del Cancro di Regina Elena
Roma, Italy
SC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
UO Ematologia e Trapianti di Cellule Staminali, A.O. S. Camillo-Forlanini
Roma, Italy
UO Ematologia, Policlinico Tor Vergata
Roma, Italy
UOC Ematologia e trapianto di cellule staminali, Policlinico Universitario Campus Bio-Medico
Roma, Italy
UOC Ematologia Policlinico Umberto I
Roma, Italy
UOC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
UOC Ematologia- Azienda Ospedaliera San Giovanni Addolorata
Roma, Italy
UO Ematologia, Istituto Clinico Humanitas
Rozzano, Italy
UOC Ematologia e centro trapianti cellule staminali emopoietiche, AOU San Giovanni Di Dio e Ruggi D'aragona
Salerno, Italy
Ematologia ASL Imperiese
Sanremo, Italy
Medicina Interna ed Ematologia, Asl 1
Savona, Italy
UOC Ematologia, Policlinico Santa Maria alle Scotte
Siena, Italy
UOC Ematologia e Trapianto Midollo Osseo, Ospedale S. G. Moscati
Taranto, Italy
SCDU Ematologia e terapie cellulari, Ospedale Mauriziano Umberto I
Torino, Italy
UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista
Torino, Italy
UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista
Torino, Italy
UO Ematologia, Ospedale Civili Ca' Foncello
Treviso, Italy
SC Ematologia, Azienda sanitaria universitaria Giuliano Isontina
Trieste, Italy
Clinica Ematologia, Azienda Ospedaliera-Universitaria Santa Maria della Misericordia
Udine, Italy
UOC Ematologia, ASST Sette Laghi, Osp. Di Circolo e Fondazione Macchi
Varese, Italy
UOC Ematologia, Azienda Ospedaliera Integrata di Verona
Verona, Italy
UOC Ematologia, Azienda Ospedaliera Integrata di Verona
Verona, Italy
UOC Ematologia, Ospedale San Bortolo
Vicenza, Italy
Francesco Passamonti, MD
+39-0332-393648
francesco.passamonti@asst-settelaghi.it
Marco Salvini, MD
marco.salvini@asst-settelaghi.it
Francesco Passamonti, MD, Principal Investigator
Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy