A ELN-Multicenter Study on Phenotypic Evolution and Clinical Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
About this trial
International multicenter retrospective observational study consisting of two parts: a nested case-control study (part A) and a comparative retrospective cohort study (part B).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None.
Trial population
Nested case-control study: the prevalence of at least one of the following proliferative conditions in the control group, a neutrophil/lymphocyte ratio (N/L ratio) above the median, an LDH above the median, being JAK2V617F homozygous and having splenomegaly. Comparative retrospective cohort study: it is known that the incidence of the composite outcome (vascular events, cancers, progression to myelofibrosis, progression to acute myeloid leukemia, death) in PV de novo patients.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
678 Participants
are grouped into 3 trial groupsGroup A: ET to PV patients
Group B: ET patients
Group C: PV de novo patients
Trial outcomes
Primary outcomes
1
Nested case-control study
To identify proliferative risk factors for progression from ET to PV in JAK2V617F positive patients.
Time frame
Up to the baseline2
Comparative retrospective cohort study
To evaluate the different disease prognosis in ET patients who have progressed to PV compared to de novo PV patients.
Time frame
Up to the baselineSecondary outcomes
1
Nested case-control study
To describe characteristics of ET patients who progressed to PV, including the timing of progression.
Time frame
At the time of progression2
Comparative retrospective cohort study
To compare the incidence of different outcomes (vascular events, progression to myelofibrosis, progression to acute myeloid leukaemia, tumours, death) in ET patients who progressed to PV and in de novo PV patients.
Time frame
At the time of progressionSponsors and contacts
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Source ClinicalTrials.gov