NCT03745378

Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,881 (actual)
• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

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

Interventions

Type	Name	Description
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,

Timeline

• Start date: 2018-05-15
• Primary completion: 2018-07-07
• Completion: 2018-09-30
• First posted: 2018-11-19
• Last updated: 2019-12-06

Locations

30 sites across 6 countries: Czechia, Germany, Israel, Italy, Spain, United Kingdom