Spots Global Cancer Trial Database for Myeloproliferative Neoplasms (MPN) and COVID-19
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Trial Identification
Brief Title: Myeloproliferative Neoplasms (MPN) and COVID-19
Official Title: Myeloproliferative Neoplasms (MPN) and COVID-19
Study ID: NCT04385160
Interventions
Study Description
Brief Summary: An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.
Detailed Description: This is an European multicenter observational study that will include around 550 MPN patients with a confirmed diagnosis of Covid-19 will be followed for at least one month. Detailed information on the clinical characteristics of these patients and their disease outcomes will be retrospectively and prospectively collected in a specific eCRF, including MPN characteristics, treatment and comorbidities pre-Covid-19, time of Covid-19 diagnosis, drugs/device used for the treatment of Covid-19, any change in MPN therapy, antithrombotic prophylaxis employed during the period of infection and - for hospitalised patients only - key blood and laboratory parameters. A particular focus will be on exploring final outcomes for patients in this study, most notably the incidence of fatal and non-fatal thrombotic events. Statistical analyses will also be performed looking for any independent factors that can significantly predict patient outcomes after Covid-19 diagnosis. Ultimately, this project will provide important insights into disease severity and progression in patients with MPN and Covid-19 and uncover the key clinical factors which drive outcomes and mortality. Results may help clinicians better understand how patient characteristics and management decisions can impact on disease trajectory when MPN and Covid-19 collide.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
New York-Presbyterian/Weill Cornell Medical Center, New York, New York, United States
National Specialised Hospital for Active Treatment of Hematological Diseases, Sofia, , Bulgaria
University hospital Dubrava-School of Medicine University of Zagreb, Zagreb, , Croatia
Hopital Saint-Louis, Paris, , France
University Hospital Halle, Department of Hematology/Oncology, Halle, Saale, Germany
University Medical Center RWTH, Aachen, , Germany
University Medicine Greifswald - Hematology, Oncology, Stem Cell Transplantation and Palliative Care, Greifswald, , Germany
University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care, Johannes Wesling Medical Center, Minden, , Germany
Ospedale San Gerardo di Monza, Monza, Monza Brianza, Italy
A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria, Alessandria, , Italy
ASST-Papa Giovanni XXIII, Bergamo, , Italy
Policlinico S.Orsola-Malpighi, Bologna, , Italy
ASST-Spedali Civili, Brescia, , Italy
AOU Ospedale Careggi, Firenze, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità, Novara, , Italy
IRCCS Policlinico San Matteo, Pavia, , Italy
Policlinico Universitario Fondazione Agostino Gemelli, Roma, , Italy
A.O.U. Città della Salute e della Scienza di Torino, Torino, , Italy
Ospedale Policlinico "G.B. Rossi" Borgo Roma, Verona, , Italy
Ospedale San Bortolo, Vicenza, , Italy
Sobas Wroclaw Medical University ·, Wrocław, , Poland
Hospital Clínic De Barcelona, Barcelona, Barcellona, Spain
Hospital del Mar, Barcelona, Barcellona, Spain
Institut Català d' Oncologia - Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
ICO L'Hospitalet - Hospital Moisès Broggi, Sant Joan Despí, Barcelona, Spain
Hospital Universitario Príncipe de Asturias, Alcalá De Henares, Madrid, Spain
Hospital General de La Palma, Breña Alta, Santa Cruz De Tenerife, Spain
Servicio de Hematología Hospital General Universitario de Albacete, Albacete, , Spain
Hospital General de Elche, Alicante, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Universitario de Burgos, Burgos, , Spain
ICO Girona Hospital Josep Trueta Servei d'hematologia, Girona, , Spain
FEA Hematología Hospital Universitario de Móstoles, Madrid, , Spain
Hospital 12 de octubre, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Gregorio Marañón, Madrid, , Spain
Hospital Moncloa, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Clínico Universitario, Valencia, , Spain
Guy's and St. Thomas' NHS Foundation Trust., London, , United Kingdom
Contact Details
Name: Tiziano Barbui, Prof
Affiliation: Fondazione per la Ricerca Ospedale di Bergamo
Role: STUDY_CHAIR
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