Clinical trial NCT03745378: Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)
Official title: Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycythemia Vera
Essential Thrombocythemia
Myelofibrosis
Keywords: Myeloproliferative neoplasms
Secondary cancer
JAK2V617F mutation
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 1881
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Matching characteristics for inclusion: sex, age at diagnosis of MPN (+/-3 years), date of MPN diagnosis (+/- 5 years), and MPN disease duration (+/- 3 years).

Brief summary: The incidence of secondary cancer (SC) in patients with myeloproliferative neoplasms (MPN) is high and comparable to that of thrombosis. However, the identification of patient subgroups that might be at increased susceptibility of developing SC has not been systematically addressed. This international case-control study (MPN-K) is aimed to elucidate the prognostic role of JAK2V617F mutation in predicting the occurrence of SC in patients with classical MPN, polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)

Detailed description: For each recruited case with concomitant diagnosis of myeloproliferative neoplasms (MPN) and secondary cancer each participating center will provide up 3 control patients (1 control for each case could be accepted but the optimal number is 3). Controls are patients with myeloproliferative neoplasms and no history of cancer. Each control will be matched to the paired case for sex, age (+/- 3 years), date of MPN diagnosis (+/- 5 years), and MPN disease duration (+/- 3 years).

Each control is censored at the date of the secondary cancer occurrence in his matched case (index date).

Data will be collected retrospectively from pre-existing medical records and reported by each center on a web-based and validated eCRF developed to record y all study data. In order to maintain patient privacy, all data records will be treated anonymously and no personal data to identify patient will be recorded: patients will be identified in the study by an alphanumeric code.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Philadelphia-negative Myeloproliferative Neoplasms (MPN) according to PVSG, 2008 and 2016 WHO criteria, including:
* Polycythemia Vera (PV)
* Essential Thrombocythemia (ET)
* Myelofibrosis (MF), including both primary and secondary MF
* Diagnosis performed between 1st January 2000 to 31 December 2016
* Diagnosis of secondary cancer(s) performed concurrently or subsequently the diagnosis of MPN

Exclusion Criteria:

- Diagnosis of cancer occurred before the diagnosis of MPN (PV, ET, MF)

Primary outcomes:
measure: Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF)
timeFrame: 10 year from diagnosis of PV, ET or MF
Secondary outcomes:
measure: Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF) in subgroups of subjects exposed to potential risk factors at diagnosis
timeFrame: 10 year from diagnosis of PV, ET or MF
measure: Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF) in the subgroups exposed to treatment
timeFrame: 10 year from diagnosis of PV, ET or MF
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Palacky University and University Hospital Olomouc, Faculty of Medecine
city: Aachen
country: Germany
facility: University Hospital RWTH - Department Oncology, Hematology, Hemostaeseology and stem cell transplantation
city: Minden
country: Germany
facility: Johannes Wesling Academic Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Asti
country: Italy
facility: Azienda Sanitaria di Asti - A.S.L. AT Ospedale Cardinal Massaia - S.C. Oncologia
city: Bergamo
country: Italy
facility: ASST- Papa Giovanni XXIII - UOC Ematologia
city: Bologna
country: Italy
facility: Ospedale S. Orsola - Malpighi - UO Ematologia
city: Catania
country: Italy
facility: U.O. Emostasi "G. Rodolico" Dipartimento di Scienze Mediche, Chirurgiche e Tecnologiche Avanzate "G.F. Ingrassia" Università degli Studi di Catania
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,
city: Firenze
country: Italy
facility: AOU Careggi di Firenze CRIMM- Center of Research and Innovation of Myeloproliferative Neoplasms - Department of Experimental and Clinical Medicine, University of Florence
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - UOC Ematologia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele Unità Operativa di Ematologia e Trapianto Midollo Osseo
city: Monza
country: Italy
facility: ASST MONZA Ospedale San Gerardo Clinica Ematologica
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo S.C Ematologia
city: Reggio Emilia
country: Italy
facility: AUSL IRCCS di Reggio Emilia Presidio Osp. Arcispedale Santa Maria Nuova - Unità Ematologia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette - S.C. Ematologia U
city: Verona
country: Italy
facility: Ospedale Borgo Roma - Unità di Ematologia
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza - U.O.C di Ematologia
city: Barcellona
country: Spain
facility: Hospital Clinic, Hematology Department
city: Barcelona
country: Spain
facility: Hospital del Mar - Haematologia Clinica
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d' Hebron - Unit Hematology
city: Santiago De Compostela
country: Spain
facility: University Clinical Hospital of Santiago De Campostela - Service of Hematology
city: Valencia
country: Spain
facility: Hospita Clinico Universitario - Hematology Department
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust - Unit Haematology
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
name: Tiziano Barbui, Prof
role: STUDY_CHAIR
affiliation: ASST-Papa Giovanni XXIII
name: Guido Finazzi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Stefano V, Ghirardi A, Masciulli A, Carobbio A, Palandri F, Vianelli N, Rossi E, Betti S, Di Veroli A, Iurlo A, Cattaneo D, Finazzi G, Bonifacio M, Scaffidi L, Patriarca A, Rumi E, Casetti IC, Stephenson C, Guglielmelli P, Elli EM, Palova M, Rapezzi D, Erez D, Gomez M, Wille K, Perez-Encinas M, Lunghi F, Angona A, Fox ML, Beggiato E, Benevolo G, Carli G, Cacciola R, McMullin MF, Tieghi A, Recasens V, Isfort S, Marchetti M, Griesshammer M, Alvarez-Larran A, Vannucchi AM, Rambaldi A, Barbui T. Arterial thrombosis in Philadelphia-negative myeloproliferative neoplasms predicts second cancer: a case-control study. Blood. 2020 Jan 30;135(5):381-386. doi: 10.1182/blood.2019002614.