Evaluation of Inflammatory Markers in ph Negative Myeloproliferative Neoplasms: Impact on Outcome and Response to Therapy. Multicenter Retro-prospective Observational Study. The INFLA-ME (INFLAmmation in Myeloproliferative Disease) Study.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of Milano Bicocca

About this trial

This study aims to observe inflammatory biomarkers and their trend over the history of the disease in patients suffering from MPN Ph negative; it also wants to identify any correlations between the aforementioned biomarkers and disease outcomes, considering first of all the occurrence of thrombo-haemorrhagic events and the evolution in the accelerated / blast phase of the disease, shedding light on new tools that can potentially guarantee a prompt and better risk stratification

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at the time of diagnosis of MPN Ph negative

Diagnosis of PV, ET, PMF or post PV and post ET MF, according to current WHO or IWG-MRT criteria (diagnosis since 2000)

Obtaining informed consent

Disqualifiers

Life expectancy of less than 6 months

Accelerated phase myelofibrosis or MPN with signs of leukemic evolution

Trial population

Adults diagnosed with PV, ET, PMF or post PV and post ET MF, according to current WHO or IWG-MRT criteria (diagnosis since 2000)

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

CBC with leukocyte formula and calculation of the NLR and PLR ratio

Time frame
60 months
2

Occurrence of arterial and venous thrombotic events

type of event, time to event after diagnosis, during illness

Time frame
60 months

Secondary outcomes

1

Measurement of new and conventional inflammatory biomarkers

at the occurrence of the transformation in the overt phase from pre-fibrotic phase in the setting of myelofibrosis or at the occurrence of the evolution of the MPN Ph negative disease in an accelerated and / or leukemic phase or after 6 months from the introduction of conventional cytoreduction or target-therapy ( JAk2 inhibitors) or 6 months after the introduction of inflammatory drugs (iron chelators)

Time frame
60 months
2

Time to thrombo-haemorrhagic events

Time frame
60 months
3

Time to death and been alive at the end of the study

Time frame
60 months
4

Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase

Time frame
60 months

Other outcomes

Sponsors and contacts

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