Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)
- Conditions
- Essential ThrombocythemiaPolycythemia VeraMyelofibrosis
- Interventions
- Other: JAK2V617F mutation
- Registration Number
- NCT03745378
- Lead Sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1881
- 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
- Diagnosis of cancer occurred before the diagnosis of MPN (PV, ET, MF)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cases JAK2V617F mutation Patients with diagnosis of Myeloproliferative Neoplasms (MPN) including Polycythemia Vera, Essential thrombocytopenia or Myelofibrosis, exposed or not exposed to JAK2V617F mutation, who experienced secondary cancer(s) diagnosed at presentation of MPN or during the course of the myeloproliferative disease. Controls JAK2V617F mutation Patients with diagnosis of Myeloproliferative Neoplasms (MPN) including Polycythemia Vera, Essential thrombocytopenia or Myelofibrosis, exposed or not exposed to JAK2V617F mutation, without history of secondary cancer.
- Primary Outcome Measures
Name Time Method Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF) 10 year from diagnosis of PV, ET or MF The ratio of number of patients showing JAK2V617F mutation on the number of patients not exposed to this mutation will be calculated in the group of subjects experiencing second cancer after diagnosis of PV, ET and MF (defined as 'cases') and related (odds ratio) with the ratio of patients exposed on those not exposed to JAK2V617F mutation in the group of subjects with no experience of secondary cancers after diagnosis of PV, ET and MF (this group is defined as 'Control' group)
- Secondary Outcome Measures
Name Time Method 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 10 year from diagnosis of PV, ET or MF Characteristics at diagnosis of patients with PV, ET and MF (including other mutations) with occurrence of second cancers (SC) are decribed and compared with those not experiencing SC after diagnosis of myloproliferative neoplasm; the ratio of number of patients exposed to potential risk factors on the number of subjects not exposed will be calculated in the group cases (as defined for primary outcome measure) and related (odds ratio) with the ratio of patient exposed versus not exposed calculated in the subgroup of control.
Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF) in the subgroups exposed to treatment 10 year from diagnosis of PV, ET or MF Group of patients exposed and not exposed to different class of treatments for PV, ET and MF are compared and related in the group of cases and control
Trial Locations
- Locations (30)
Ospedale S. Orsola - Malpighi - UO Ematologia
🇮🇹Bologna, Italy
Meir Medical Center
🇮🇱Kfar Saba, Israel
University Hospital RWTH - Department Oncology, Hematology, Hemostaeseology and stem cell transplantation
🇩🇪Aachen, Germany
Palacky University and University Hospital Olomouc, Faculty of Medecine
🇨🇿Olomouc, Czechia
Johannes Wesling Academic Medical Center
🇩🇪Minden, Germany
Azienda Sanitaria di Asti - A.S.L. AT Ospedale Cardinal Massaia - S.C. Oncologia
🇮🇹Asti, Italy
U.O. Emostasi "G. Rodolico" Dipartimento di Scienze Mediche, Chirurgiche e Tecnologiche Avanzate "G.F. Ingrassia" Università degli Studi di Catania
🇮🇹Catania, Italy
AOU Careggi di Firenze CRIMM- Center of Research and Innovation of Myeloproliferative Neoplasms - Department of Experimental and Clinical Medicine, University of Florence
🇮🇹Firenze, Italy
ASST- Papa Giovanni XXIII - UOC Ematologia
🇮🇹Bergamo, Italy
Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,
🇮🇹Cuneo, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - UOC Ematologia
🇮🇹Milano, Italy
ASST MONZA Ospedale San Gerardo Clinica Ematologica
🇮🇹Monza, Italy
A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette - S.C. Ematologia U
🇮🇹Torino, Italy
IRCCS Ospedale San Raffaele Unità Operativa di Ematologia e Trapianto Midollo Osseo
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
🇮🇹Napoli, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
🇮🇹Novara, Italy
Fondazione IRCCS Policlinico San Matteo S.C Ematologia
🇮🇹Pavia, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia
🇮🇹Roma, Italy
AUSL IRCCS di Reggio Emilia Presidio Osp. Arcispedale Santa Maria Nuova - Unità Ematologia
🇮🇹Reggio Emilia, Italy
Ospedale Borgo Roma - Unità di Ematologia
🇮🇹Verona, Italy
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia
🇮🇹Torino, Italy
Hospital Clinic, Hematology Department
🇪🇸Barcellona, Spain
Hospital del Mar - Haematologia Clinica
🇪🇸Barcelona, Spain
Ospedale San Bortolo di Vicenza - U.O.C di Ematologia
🇮🇹Vicenza, Italy
Hospital Universitario Vall d' Hebron - Unit Hematology
🇪🇸Barcelona, Spain
Hospita Clinico Universitario - Hematology Department
🇪🇸Valencia, Spain
University Clinical Hospital of Santiago De Campostela - Service of Hematology
🇪🇸Santiago De Compostela, Spain
Miguel Servet University Hospital
🇪🇸Zaragoza, Spain
Belfast Health and Social Care Trust - Unit Haematology
🇬🇧Belfast, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom