COVID19-hematological Malignancies: the Italian Hematology Alliance
NCT ID: NCT04352556
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2020-04-07
2022-10-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* SARS-CoV-2 negative test.
18 Years
ALL
No
Sponsors
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Ospedale di Circolo - Fondazione Macchi
OTHER
Responsible Party
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Francesco Passamonti
Principal Investigator
Principal Investigators
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Francesco Passamonti, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy
Locations
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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
Florence, , 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
Milan, , Italy
SC Ematologia, Istituto Nazionale dei Tumori
Milan, , Italy
SC Ematologia, Ospedale Niguarda
Milan, , Italy
UO Ematologia, IRCCS Ospedale San Raffaele
Milan, , Italy
UO Servizio di Ematologia e Medicina Trasfusionale, Ospedale Luigi Sacco
Milan, , Italy
UOC Ematologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , 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
Padua, , 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
Countries
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Central Contacts
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Facility Contacts
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Marco Ladetto, MD
Role: primary
Attilio Olivieri, MD
Role: primary
Piero Galieni, MD
Role: primary
Michele Spina, MD
Role: primary
Pellegrino Musto, MD
Role: primary
Attilio Guarini, MD
Role: primary
Anna Conconi, MD
Role: primary
Michele Cavo, MD
Role: primary
Atto Billio, MD
Role: primary
Domenico Russo, MD
Role: primary
Chiara Cattaneo, MD
Role: primary
Fabrizio Ciambelli, MD
Role: primary
Giorgio La Nasa, MD
Role: primary
Francesco Di Raimondo, MD
Role: primary
Mauro Turrini, MD
Role: primary
Massimo Gentile, MD
Role: primary
Alfredo Molteni, MD
Role: primary
Massimo Massaia, MD
Role: primary
Antonio Cuneo, MD
Role: primary
Alberto Bosi, MD
Role: primary
Celestino Ferrandina, MD
Role: primary
Giovanni Martinelli, MD
Role: primary
Roberto Lemoli, MD
Role: primary
Emanuele Angelucci, MD
Role: primary
Nicola Di Renzo, MD
Role: primary
Alessandro Corso, MD
Role: primary
Annarosa Cuccaro, MD
Role: primary
Alessandro Inzoli, MD
Role: primary
Caterina Musolino, MD
Role: primary
Renato Bassan, MD
Role: primary
Corrado Tarella, MD
Role: primary
Paolo Corradini, MD
Role: primary
Roberto Cairoli, MD
Role: primary
Fabio Ciceri, MD
Role: primary
Augusto Federici, MD
Role: primary
Nicola Fracchiolla, MD
Role: primary
Mario Luppi, MD
Role: primary
Carlo Gambacorti Passerini, MD
Role: primary
Antonio Pinto, MD
Role: primary
Fabrizio Pane, MD
Role: primary
Felicetto Ferrara, MD
Role: primary
Gianluca Gaidano, MD
Role: primary
Daniela Cilloni, MD
Role: primary
Giampietro Semenzato, MD
Role: primary
Sergio Siragusa, MD
Role: primary
Nicola Giuliani, MD
Role: primary
Luca Arcaini, MD
Role: primary
Brunangelo Falini, MD
Role: primary
Giuseppe Visani, MD
Role: primary
Antonio Spadano, MD
Role: primary
Daniele Vallisa, MD
Role: primary
Sara Galimberti, MD
Role: primary
Francesco Lanza, MD
Role: primary
Bruno Martino, MD
Role: primary
Francesco Merli, MD
Role: primary
Patrizia Tosi, MD
Role: primary
Agostino Tafuri, MD
Role: primary
Francesco Marchesi, MD
Role: primary
Livio Pagano, MD
Role: primary
Luigi Rigacci, MD
Role: primary
Adriano Venditti, MD
Role: primary
Giuseppe Avvisati, MD
Role: primary
Maurizio Martelli, MD
Role: primary
Valerio De Stefano, MD
Role: primary
Laura Cudillo, MD
Role: primary
Matteo Della Porta, MD
Role: primary
Carmine Selleri, MD
Role: primary
Tullio Calzamiglia, MD
Role: primary
Marina Cavaliere, MD
Role: primary
Monica Bocchia, MD
Role: primary
Patrizio Mazza, MD
Role: primary
Carmen Fava, MD
Role: primary
Benedetto Bruno, MD
Role: primary
Alessandro Busca, MD
Role: primary
Filippo Gherlinzoni, MD
Role: primary
Francesco Zaja, MD
Role: primary
Renato Fanin, MD
Role: primary
Francesco Passamonti, MD
Role: primary
Mauro Krampera, MD
Role: primary
Carlo Visco, MD
Role: primary
Marco Ruggeri, MD
Role: primary
References
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Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
Xia Y, Jin R, Zhao J, Li W, Shen H. Risk of COVID-19 for patients with cancer. Lancet Oncol. 2020 Apr;21(4):e180. doi: 10.1016/S1470-2045(20)30150-9. Epub 2020 Mar 3. No abstract available.
Wang H, Zhang L. Risk of COVID-19 for patients with cancer. Lancet Oncol. 2020 Apr;21(4):e181. doi: 10.1016/S1470-2045(20)30149-2. Epub 2020 Mar 3. No abstract available.
Corrao G, Rea F, Di Martino M, De Palma R, Scondotto S, Fusco D, Lallo A, Belotti LMB, Ferrante M, Pollina Addario S, Merlino L, Mancia G, Carle F. Developing and validating a novel multisource comorbidity score from administrative data: a large population-based cohort study from Italy. BMJ Open. 2017 Dec 26;7(12):e019503. doi: 10.1136/bmjopen-2017-019503.
Visco C, Marcheselli L, Mina R, Sassone M, Guidetti A, Penna D, Cattaneo C, Bonuomo V, Busca A, Ferreri AJM, Bruna R, Petrucci L, Cairoli R, Salvini M, Bertu L, Ladetto M, Pilerci S, Pinto A, Ramadan S, Marchesi F, Cavo M, Arcaini L, Coviello E, Romano A, Musto P, Massaia M, Fracchiolla N, Marchetti M, Scattolin A, Tisi MC, Cuneo A, Della Porta M, Trentin L, Turrini M, Gherlinzoni F, Tafuri A, Galimberti S, Bocchia M, Cardinali V, Cilloni D, Corso A, Armiento D, Rigacci L, La Barbera EO, Gambacorti-Passerini C, Visani G, Vallisa D, Venditti A, Selleri C, Conconi A, Tosi P, Lanza F, Candoni A, Krampera M, Corradini P, Passamonti F, Merli F; ITA-HEMA-COV investigators. A prognostic model for patients with lymphoma and COVID-19: a multicentre cohort study. Blood Adv. 2022 Jan 11;6(1):327-338. doi: 10.1182/bloodadvances.2021005691.
Passamonti F, Cattaneo C, Arcaini L, Bruna R, Cavo M, Merli F, Angelucci E, Krampera M, Cairoli R, Della Porta MG, Fracchiolla N, Ladetto M, Gambacorti Passerini C, Salvini M, Marchetti M, Lemoli R, Molteni A, Busca A, Cuneo A, Romano A, Giuliani N, Galimberti S, Corso A, Morotti A, Falini B, Billio A, Gherlinzoni F, Visani G, Tisi MC, Tafuri A, Tosi P, Lanza F, Massaia M, Turrini M, Ferrara F, Gurrieri C, Vallisa D, Martelli M, Derenzini E, Guarini A, Conconi A, Cuccaro A, Cudillo L, Russo D, Ciambelli F, Scattolin AM, Luppi M, Selleri C, Ortu La Barbera E, Ferrandina C, Di Renzo N, Olivieri A, Bocchia M, Gentile M, Marchesi F, Musto P, Federici AB, Candoni A, Venditti A, Fava C, Pinto A, Galieni P, Rigacci L, Armiento D, Pane F, Oberti M, Zappasodi P, Visco C, Franchi M, Grossi PA, Bertu L, Corrao G, Pagano L, Corradini P; ITA-HEMA-COV Investigators. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study. Lancet Haematol. 2020 Oct;7(10):e737-e745. doi: 10.1016/S2352-3026(20)30251-9. Epub 2020 Aug 13.
Other Identifiers
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HM-COVID19-Italy
Identifier Type: -
Identifier Source: org_study_id
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