Polycythemia VeraMPN-KNCT03745378
Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)
An observational study of Polycythemia Vera and Essential Thrombocythemia, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 30 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis
- What is being tested?
- JAK2V617F mutation
- How many people
- 1,881 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 15 May 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Diagnosis of cancer occurred before the diagnosis of MPN (PV, ET, MF)
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
Italy18 sites
Azienda Sanitaria di Asti - A.S.L. AT Ospedale Cardinal Massaia - S.C. Oncologia
Asti, 14100
ASST- Papa Giovanni XXIII - UOC Ematologia
Bergamo, 24127
Ospedale S. Orsola - Malpighi - UO Ematologia
Bologna, 40138
U.O. Emostasi "G. Rodolico" Dipartimento di Scienze Mediche, Chirurgiche e Tecnologiche Avanzate "G.F. Ingrassia" Università degli Studi di Catania
Catania, 95123
Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,
Cuneo, 2100
AOU Careggi di Firenze CRIMM- Center of Research and Innovation of Myeloproliferative Neoplasms - Department of Experimental and Clinical Medicine, University of Florence
Florence, 50134
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - UOC Ematologia
Milan, 20122
IRCCS Ospedale San Raffaele Unità Operativa di Ematologia e Trapianto Midollo Osseo
Milan, 20132
ASST MONZA Ospedale San Gerardo Clinica Ematologica
Monza, 20900
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Naples, 80131
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
Novara, 28100
Fondazione IRCCS Policlinico San Matteo S.C Ematologia
Pavia, 27100
AUSL IRCCS di Reggio Emilia Presidio Osp. Arcispedale Santa Maria Nuova - Unità Ematologia
Reggio Emilia, 42123
Fondazione Policlinico Universitario A. Gemelli IRCCS UCSC Ematologia
Roma, 00168
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia
Torino, 10126
A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette - S.C. Ematologia U
Torino, 10126
Ospedale Borgo Roma - Unità di Ematologia
Verona, 37134
Ospedale San Bortolo di Vicenza - U.O.C di Ematologia
Vicenza, 36100
Spain6 sites
Hospital Clinic, Hematology Department
Barcelona, 08034
Hospital del Mar - Haematologia Clinica
Barcelona
Hospital Universitario Vall d' Hebron - Unit Hematology
Barcelona
University Clinical Hospital of Santiago De Campostela - Service of Hematology
Santiago de Compostela
Hospita Clinico Universitario - Hematology Department
Valencia
Miguel Servet University Hospital
Zaragoza
Germany2 sites
University Hospital RWTH - Department Oncology, Hematology, Hemostaeseology and stem cell transplantation
Aachen
Johannes Wesling Academic Medical Center
Minden
United Kingdom2 sites
Belfast Health and Social Care Trust - Unit Haematology
Belfast
Guy's and St Thomas' NHS Foundation Trust
London
Czechia1 site
Palacky University and University Hospital Olomouc, Faculty of Medecine
Olomouc
About this study
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)
Read the 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.
- Conditions
- Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis
- Being tested
- JAK2V617F mutation
- Keywords
- Myeloproliferative neoplasms, Secondary cancer, JAK2V617F mutation
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis, Myeloproliferative Disorders, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: JAK2V617F mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: 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
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
Measured: 10 year from diagnosis of PV, ET or MF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start15 May 2018
- Primary completion7 Jul 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,881 participants (actual)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiziano Barbui, Prof, Study chair, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSGuido Finazzi, Dr, Principal investigator, ASST-Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745378
- Sponsor's protocol ID
- MPN-K - FROM/O2- 2017
- Acronym
- MPN-K
- Status last verified
- Dec 2019
- First submitted
- 15 Oct 2018
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31869407
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)
- ClinicalTrials.gov ID
- NCT03745378
- Acronym / sponsor ID
- MPN-K / MPN-K - FROM/O2- 2017
- Conditions
- Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis
- Keywords
- Myeloproliferative neoplasms, Secondary cancer, JAK2V617F mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,881 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: JAK2V617F mutationPatients 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 | – | Other: JAK2V617F mutationPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of cancer occurred before the diagnosis of MPN (PV, ET, MF)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAK2V617F mutationJAK2 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, | Other | Cases, Controls |
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Derived from this study: PubMed 31869407De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiziano Barbui, Prof study chair
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Guido Finazzi, Dr principal investigator
ASST-Papa Giovanni XXIII
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera and Essential Thrombocythemia, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 30 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy, Spain, Germany, United Kingdom, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.