NCT03745378

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)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,881

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
6 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

October 15, 2018

Last Update Submit

December 5, 2019

Conditions

Polycythemia VeraEssential ThrombocythemiaMyelofibrosis

Keywords

Myeloproliferative neoplasmsSecondary cancerJAK2V617F mutation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (2)

Cases

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.

Other: JAK2V617F mutation

Controls

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.

Other: JAK2V617F mutation

Interventions

JAK2V617F mutationOTHER

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,

CasesControls

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Palacky University and University Hospital Olomouc, Faculty of Medecine

Olomouc, Czechia

Location

University Hospital RWTH - Department Oncology, Hematology, Hemostaeseology and stem cell transplantation

Aachen, Germany

Location

Johannes Wesling Academic Medical Center

Minden, Germany

Location

Meir Medical Center

Kfar Saba, Israel

Location

Azienda Sanitaria di Asti - A.S.L. AT Ospedale Cardinal Massaia - S.C. Oncologia

Asti, 14100, Italy

Location

ASST- Papa Giovanni XXIII - UOC Ematologia

Bergamo, 24127, Italy

Location

Ospedale S. Orsola - Malpighi - UO Ematologia

Bologna, 40138, Italy

Location

U.O. Emostasi "G. Rodolico" Dipartimento di Scienze Mediche, Chirurgiche e Tecnologiche Avanzate "G.F. Ingrassia" Università degli Studi di Catania

Catania, 95123, Italy

Location

Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,

Cuneo, 2100, Italy

Location

AOU Careggi di Firenze CRIMM- Center of Research and Innovation of Myeloproliferative Neoplasms - Department of Experimental and Clinical Medicine, University of Florence

Florence, 50134, Italy

Location

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - UOC Ematologia

Milan, 20122, Italy

Location

IRCCS Ospedale San Raffaele Unità Operativa di Ematologia e Trapianto Midollo Osseo

Milan, 20132, Italy

Location

ASST MONZA Ospedale San Gerardo Clinica Ematologica

Monza, 20900, Italy

Location

Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

Novara, 28100, Italy

Location

Fondazione IRCCS Policlinico San Matteo S.C Ematologia

Pavia, 27100, Italy

Location

AUSL IRCCS di Reggio Emilia Presidio Osp. Arcispedale Santa Maria Nuova - Unità Ematologia

Reggio Emilia, 42123, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia

Roma, 00168, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia

Torino, 10126, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette - S.C. Ematologia U

Torino, 10126, Italy

Location

Ospedale Borgo Roma - Unità di Ematologia

Verona, 37134, Italy

Location

Ospedale San Bortolo di Vicenza - U.O.C di Ematologia

Vicenza, 36100, Italy

Location

Hospital Clinic, Hematology Department

Barcelona, 08034, Spain

Location

Hospital del Mar - Haematologia Clinica

Barcelona, Spain

Location

Hospital Universitario Vall d' Hebron - Unit Hematology

Barcelona, Spain

Location

University Clinical Hospital of Santiago De Campostela - Service of Hematology

Santiago de Compostela, Spain

Location

Hospita Clinico Universitario - Hematology Department

Valencia, Spain

Location

Miguel Servet University Hospital

Zaragoza, Spain

Location

Belfast Health and Social Care Trust - Unit Haematology

Belfast, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31869407DERIVED

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, EssentialPrimary MyelofibrosisMyeloproliferative DisordersNeoplasms, Second Primary

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

Study Officials

  • Tiziano Barbui, Prof

    FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

    STUDY CHAIR

  • Guido Finazzi, Dr

    ASST-Papa Giovanni XXIII

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2018

First Posted

November 19, 2018

Study Start

May 15, 2018

Primary Completion

July 7, 2018

Study Completion

September 30, 2018

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations

CZ(1)GB(2)IT(18)ES(6)DE(2)IL(1)