Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)

Myelofibrosis Clinical Trial

— MPN-K  

Official title:

Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745378
• Other study ID #: MPN-K - FROM/O2- 2017
• Status: Completed
• Start date: May 15, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: December 2019
• Source: Fondazione per la Ricerca Ospedale Maggiore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 1881
• Est. completion date: September 30, 2018
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Myelofibrosis
• Myeloproliferative Disorders
• Neoplasm Metastasis
• Neoplasms
• Polycythemia
• Polycythemia Vera
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Other:
• JAK2V617F mutation
JAK2 V617F is attached to the cytosolic juxtamembrane region of dimeric cytokine receptors, such as EpoR or MPL (TpoR); The JAK2V617F mutation results from a guanine to thymine change at nucleotide 1849 of the cDNA, in exon 14 of the gene. This valine is located at one of the predicted interfaces between JH1 and JH2 domains,

Locations

Country	Name	City	State
Czechia	Palacky University and University Hospital Olomouc, Faculty of Medecine	Olomouc
Germany	University Hospital RWTH - Department Oncology, Hematology, Hemostaeseology and stem cell transplantation	Aachen
Germany	Johannes Wesling Academic Medical Center	Minden
Israel	Meir Medical Center	Kfar Saba
Italy	Azienda Sanitaria di Asti - A.S.L. AT Ospedale Cardinal Massaia - S.C. Oncologia	Asti
Italy	ASST- Papa Giovanni XXIII - UOC Ematologia	Bergamo
Italy	Ospedale S. Orsola - Malpighi - UO Ematologia	Bologna
Italy	U.O. Emostasi "G. Rodolico" Dipartimento di Scienze Mediche, Chirurgiche e Tecnologiche Avanzate "G.F. Ingrassia" Università degli Studi di Catania	Catania
Italy	Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,	Cuneo
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	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - UOC Ematologia	Milano
Italy	IRCCS Ospedale San Raffaele Unità Operativa di Ematologia e Trapianto Midollo Osseo	Milano
Italy	ASST MONZA Ospedale San Gerardo Clinica Ematologica	Monza
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	AUSL IRCCS di Reggio Emilia Presidio Osp. Arcispedale Santa Maria Nuova - Unità Ematologia	Reggio Emilia
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia	Roma
Italy	A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia	Torino
Italy	A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette - S.C. Ematologia U	Torino
Italy	Ospedale Borgo Roma - Unità di Ematologia	Verona
Italy	Ospedale San Bortolo di Vicenza - U.O.C di Ematologia	Vicenza
Spain	Hospital Clinic, Hematology Department	Barcellona
Spain	Hospital del Mar - Haematologia Clinica	Barcelona
Spain	Hospital Universitario Vall d' Hebron - Unit Hematology	Barcelona
Spain	University Clinical Hospital of Santiago De Campostela - Service of Hematology	Santiago De Compostela
Spain	Hospita Clinico Universitario - Hematology Department	Valencia
Spain	Miguel Servet University Hospital	Zaragoza
United Kingdom	Belfast Health and Social Care Trust - Unit Haematology	Belfast
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Countries where clinical trial is conducted

Czechia,  Germany,  Israel,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (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)	10 year from diagnosis of PV, ET or MF
Secondary	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	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.	10 year from diagnosis of PV, ET or MF
Secondary	Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF) in the subgroups exposed to treatment	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	10 year from diagnosis of PV, ET or MF