Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study) (MPN-K)

December 5, 2019 updated by: Fondazione per la Ricerca Ospedale Maggiore
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1881

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia
        • Palacky University and University Hospital Olomouc, Faculty of Medecine
  • Germany
      • Aachen, Germany
        • University Hospital RWTH - Department Oncology, Hematology, Hemostaeseology and stem cell transplantation
      • Minden, Germany
        • Johannes Wesling Academic Medical Center
  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center
  • Italy
      • Asti, Italy, 14100
        • Azienda Sanitaria di Asti - A.S.L. AT Ospedale Cardinal Massaia - S.C. Oncologia
      • Bergamo, Italy, 24127
        • ASST- Papa Giovanni XXIII - UOC Ematologia
      • Bologna, Italy, 40138
        • Ospedale S. Orsola - Malpighi - UO Ematologia
      • Catania, Italy, 95123
        • U.O. Emostasi "G. Rodolico" Dipartimento di Scienze Mediche, Chirurgiche e Tecnologiche Avanzate "G.F. Ingrassia" Università degli Studi di Catania
      • Cuneo, Italy, 2100
        • Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,
      • Firenze, Italy, 50134
        • AOU Careggi di Firenze CRIMM- Center of Research and Innovation of Myeloproliferative Neoplasms - Department of Experimental and Clinical Medicine, University of Florence
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - UOC Ematologia
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele Unità Operativa di Ematologia e Trapianto Midollo Osseo
      • Monza, Italy, 20900
        • ASST MONZA Ospedale San Gerardo Clinica Ematologica
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
      • Novara, Italy, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo S.C Ematologia
      • Reggio Emilia, Italy, 42123
        • AUSL IRCCS di Reggio Emilia Presidio Osp. Arcispedale Santa Maria Nuova - Unità Ematologia
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette - S.C. Ematologia U
      • Verona, Italy, 37134
        • Ospedale Borgo Roma - Unità di Ematologia
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo di Vicenza - U.O.C di Ematologia
  • Spain
      • Barcellona, Spain, 08034
        • Hospital Clinic, Hematology Department
      • Barcelona, Spain
        • Hospital del Mar - Haematologia Clinica
      • Barcelona, Spain
        • Hospital Universitario Vall d' Hebron - Unit Hematology
      • Santiago De Compostela, Spain
        • University Clinical Hospital of Santiago De Campostela - Service of Hematology
      • Valencia, Spain
        • Hospita Clinico Universitario - Hematology Department
      • Zaragoza, Spain
        • Miguel Servet University Hospital
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast Health and Social Care Trust - Unit Haematology
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with secondary cancers after diagnosis of Polycythemia Vera (PV), Essential Trombocythemia (ET) and Myelofibrosis (MF)
Time Frame: 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)
10 year from diagnosis of PV, ET or MF

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
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
Time Frame: 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
10 year from diagnosis of PV, ET or MF

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione per la Ricerca Ospedale Maggiore

Investigators

  • Study Chair: Tiziano Barbui, Prof, Fondazione per la Ricerca Ospedale Maggiore
  • Principal Investigator: Guido Finazzi, Dr, ASST-Papa Giovanni XXIII

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2018

Primary Completion (ACTUAL)

July 7, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (ACTUAL)

November 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPN-K - FROM/O2- 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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