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Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)

NCT ID: NCT03745378

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1881 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-15

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Polycythemia Vera Essential Thrombocythemia Myelofibrosis

Keywords

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Myeloproliferative neoplasms Secondary cancer JAK2V617F mutation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

JAK2V617F mutation

Intervention Type OTHER

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,

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.

JAK2V617F mutation

Intervention Type OTHER

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,

Interventions

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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,

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiziano Barbui, Prof

Role: STUDY_CHAIR

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Guido Finazzi, Dr

Role: PRINCIPAL_INVESTIGATOR

ASST-Papa Giovanni XXIII

Locations

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Palacky University and University Hospital Olomouc, Faculty of Medecine

Olomouc, , Czechia

Site Status

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

Aachen, , Germany

Site Status

Johannes Wesling Academic Medical Center

Minden, , Germany

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

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

Asti, , Italy

Site Status

ASST- Papa Giovanni XXIII - UOC Ematologia

Bergamo, , Italy

Site Status

Ospedale S. Orsola - Malpighi - UO Ematologia

Bologna, , Italy

Site Status

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

Catania, , Italy

Site Status

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

Cuneo, , Italy

Site Status

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

Florence, , Italy

Site Status

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

Milan, , Italy

Site Status

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

Milan, , Italy

Site Status

ASST MONZA Ospedale San Gerardo Clinica Ematologica

Monza, , Italy

Site Status

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

Napoli, , Italy

Site Status

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

Novara, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo S.C Ematologia

Pavia, , Italy

Site Status

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

Reggio Emilia, , Italy

Site Status

Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia

Roma, , Italy

Site Status

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

Torino, , Italy

Site Status

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

Torino, , Italy

Site Status

Ospedale Borgo Roma - Unità di Ematologia

Verona, , Italy

Site Status

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

Vicenza, , Italy

Site Status

Hospital Clinic, Hematology Department

Barcelona, , Spain

Site Status

Hospital del Mar - Haematologia Clinica

Barcelona, , Spain

Site Status

Hospital Universitario Vall d' Hebron - Unit Hematology

Barcelona, , Spain

Site Status

University Clinical Hospital of Santiago De Campostela - Service of Hematology

Santiago de Compostela, , Spain

Site Status

Hospita Clinico Universitario - Hematology Department

Valencia, , Spain

Site Status

Miguel Servet University Hospital

Zaragoza, , Spain

Site Status

Belfast Health and Social Care Trust - Unit Haematology

Belfast, , United Kingdom

Site Status

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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Czechia Germany Israel Italy Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31869407 (View on PubMed)

Other Identifiers

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MPN-K - FROM/O2- 2017

Identifier Type: -

Identifier Source: org_study_id