COVID19-hematological Malignancies: the Italian Hematology Alliance
- Conditions
- Hematological MalignanciesSARS-CoV-2 Infection
- Registration Number
- NCT04352556
- Lead Sponsor
- Ospedale di Circolo - Fondazione Macchi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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.
- Hematological diseases, other than hematological malignancies.
- SARS-CoV-2 negative test.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate mortality. At 2 months from study initiation The percentage of HM patients with COVID-19 who died.
To evaluate potential predictive biochemical parameters of mortality. At 2 months from study initiation We will assess the correlation between some biochemical parameters at diagnosis of COVID (i.e. hemoglobin, platelets, lymphocytes, clotting tests, CRP), each on the basis of its specific unit of measure, and mortality.
To evaluate COVID severity as predictive parameter of mortality. At 2 months from study initiation We will assess the correlation between COVID severity \[mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 \< 300 and/or lung infiltrates \> 50%) and critical (respiratory failure, septic shock, and/or multiple organ disfunction or failure)\] and mortality
To evaluate potential predictive HM-related parameters of mortality. At 2 months from study initiation We will assess the correlation between HM-related parameters at diagnosis of COVID \[i.e. disease type (leukemia, lymphomas, myeloma), disease status (remission / stable / progression), therapy status (on / off therapy)\] and mortality.
- Secondary Outcome Measures
Name Time Method Evolution of HM At 2 months from study initiation Assessment of HM status post SARS-CoV-2 infection stratified as no implication, loss of response, progression of the hematological disease.
To evaluate admission to ICU requiring mechanical ventilation or death per characteristics At 2 months from study initiation Percentage of HM patients being admitted to ICU requiring mechanical ventilation, or death stratified per disease type, status, per off-therapy/on-therapy, per type of therapy (chemo, immunotherapy, cell therapy, stem cell transplant).
Epidemiology of patients with HM infected by SARS-CoV-2with any spectrum of illness severity At 6 months from study initiation Description of the different types of hematological malignancies (WHO criteria) in patients with SARS-CoV-2 infection. All aggregated data will be stratified on the basis of COVID severity: mild (non-pneumonia and mild pneumonia), severe (dyspnea, respiratory frequency ≥ 30/min, SpO2 ≤ 93%, PaO2/FiO2 \< 300 and/or lung infiltrates \> 50%) and critical disease (respiratory failure, septic shock, and/or multiple organ disfunction or failure)
Definition of complete clinical picture of COVID-19 in HM At 2 months from study initiation Characterization of clinical and biochemical profile of patients with SARS-CoV-2 positivity.
Viral dynamics in infected HM patients At 12 months from study initiation
Trial Locations
- Locations (78)
SC Ematologia Ospedale SS Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
UOC Ematologia, Ospedali Riuniti
🇮🇹Ancona, Italy
SC Ematologia Ospedale S. Croce
🇮🇹Cuneo, Italy
UOC Oncologia ASST Lodi
🇮🇹Lodi, Italy
UO Ematologia, Ospedale dell'Angelo di Mestre
🇮🇹Mestre, Italy
UO Ematologia Policlinico di Modena
🇮🇹Modena, Italy
Ospedale san Luigi Gonzaga
🇮🇹Orbassano, Italy
SC Oncologia Medica, CRO
🇮🇹Aviano, Italy
UOC Ematologia e Terapia Cellulare, Ospedale Mazzoni
🇮🇹Ascoli Piceno, Italy
UOC Ematologia, I.R.C.C.S Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
SC Ematologia, Policlinico Bari
🇮🇹Bari, Italy
SSD Ematologia, Ospedale degli Infermi
🇮🇹Biella, Italy
Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano
🇮🇹Bolzano, Italy
UOC Ematologia, Azienda Ospedaliero-Universitaria Policlinico S.Orsola-Malpighi,
🇮🇹Bologna, 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
UO Ematologia e CTMO, ASST Cremona
🇮🇹Cremona, Italy
Ematologia, Ospedale Valduce
🇮🇹Como, Italy
UOC Ematologia, Azienda Ospedaliera di Cosenza
🇮🇹Cosenza, Italy
UOC Ematologia, AOU Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
UOC, Ematologia Azienda Ospedaliero Universitaria Arcispedale S. Anna
🇮🇹Ferrara, Italy
UO Ematologia, Ospedale Policlinico S.Martino IRCCS
🇮🇹Genova, Italy
S.O.D. Ematologia, Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Italy
IRST-IRCC di Meldola
🇮🇹Forlì, Italy
UOC Ematologia, Policlinico Ospedali Riuniti
🇮🇹Foggia, Italy
UO Ematologia, Ospedale Policlinico San Martino
🇮🇹Genova, Italy
UO Dipartimento di Ematologia, USL 6
🇮🇹Livorno, Italy
UOC di Ematologia e Trapianto di Cellule Staminali, P.O. Vito Fazzi
🇮🇹Lecce, Italy
UOC di Ematologia, Ospedale di Legnano
🇮🇹Legnano, Italy
UOC Ematologia Azienda Ospedaliera Universitaria "G.Martino"
🇮🇹Messina, Italy
SC Ematologia, Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Ematologia, IEO
🇮🇹Milano, Italy
SC Ematologia, Ospedale Niguarda
🇮🇹Milano, Italy
UOC Ematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
UO Ematologia, IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
UO Servizio di Ematologia e Medicina Trasfusionale, Ospedale Luigi Sacco
🇮🇹Milano, Italy
SC Ematologia Istituto Nazionale Tumori - IRCCS "Fondazione G. Pascale",
🇮🇹Napoli, Italy
UOC Ematologia, Ospedale S. Gerardo
🇮🇹Monza, Italy
UOC Ematologia e Trapianti di Midollo, AOU Federico II
🇮🇹Napoli, Italy
UOC Ematologia, Ospedale Antonio Cardarelli
🇮🇹Napoli, Italy
Ematologia Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
UOC Ematologia e CTMO, Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
UOC Ematologia, Azienda Ospedaliero-Universitaria Maggiore della Carità
🇮🇹Novara, Italy
SC Ematologia e Trapianto di Midollo Osseo, Azienda Ospedaliera di Perugia
🇮🇹Perugia, Italy
UO Ematologia e CTMO, Azienda Ospedaliera Ospedali Riuniti
🇮🇹Pesaro, Italy
UO Ematologia, Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
SC Ematologia, Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, 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
AOU Azienda Ospedaliera Universitaria Sant'Andrea
🇮🇹Roma, Italy
UO Ematologia, Ospedale Infermi
🇮🇹Rimini, Italy
UO Ematologia e Trapianti di Cellule Staminali, A.O. S. Camillo-Forlanini
🇮🇹Roma, Italy
SC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Italy
IFO - Ematologia e Trapianto Cellule -Istituto Nazionale del Cancro di Regina Elena
🇮🇹Roma, Italy
UO Ematologia, Policlinico Tor Vergata
🇮🇹Roma, Italy
UOC Ematologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Italy
UOC Ematologia e trapianto di cellule staminali, Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Italy
UOC Ematologia- Azienda Ospedaliera San Giovanni Addolorata
🇮🇹Roma, Italy
UOC Ematologia Policlinico Umberto I
🇮🇹Roma, Italy
UO Ematologia, Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Ematologia ASL Imperiese
🇮🇹Sanremo, Italy
UOC Ematologia e centro trapianti cellule staminali emopoietiche, AOU San Giovanni Di Dio e Ruggi D'aragona
🇮🇹Salerno, Italy
UOC Ematologia e Trapianto Midollo Osseo, Ospedale S. G. Moscati
🇮🇹Taranto, Italy
UOC Ematologia, Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
SCDU Ematologia e terapie cellulari, Ospedale Mauriziano Umberto I
🇮🇹Torino, Italy
Medicina Interna ed Ematologia, Asl 1
🇮🇹Savona, Italy
UO Ematologia, Ospedale Universitario Molinette San Giovanni Battista
🇮🇹Torino, Italy
UO Ematologia, Ospedale Civili Ca' Foncello
🇮🇹Treviso, Italy
Clinica Ematologia, Azienda Ospedaliera-Universitaria Santa Maria della Misericordia
🇮🇹Udine, Italy
SC Ematologia, Azienda sanitaria universitaria Giuliano Isontina
🇮🇹Trieste, 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, Ospedale San Bortolo
🇮🇹Vicenza, Italy