Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Status: Completed

Conditions: Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia

Treatments: Other: JAK2V617F mutation

Study type: Observational

Funder types: Other

Identifiers

NCT03745378

MPN-K - FROM/O2- 2017

Details and patient eligibility

About

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)

Full 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.

Enrollment: 1,881 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

1,881 participants in 2 patient groups

Cases

Description:

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.

Treatment:

Other: JAK2V617F mutation

Controls

Description:

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.

Treatment:

Other: JAK2V617F mutation