Clinical trial NCT05553873: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloproliferative Disease
Inflammatory Markers
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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)

Brief summary: 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* Life expectancy of less than 6 months
* Accelerated phase myelofibrosis or MPN with signs of leukemic evolution

Primary outcomes:
measure: CBC with leukocyte formula and calculation of the NLR and PLR ratio
timeFrame: 60 months
measure: Occurrence of arterial and venous thrombotic events
timeFrame: 60 months
Secondary outcomes:
measure: Measurement of new and conventional inflammatory biomarkers
timeFrame: 60 months
measure: Time to thrombo-haemorrhagic events
timeFrame: 60 months
measure: Time to death and been alive at the end of the study
timeFrame: 60 months
measure: Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase
timeFrame: 60 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria Consorziale Policlinico
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele
city: Napoli
country: Italy
facility: Ospedale Universitario Federico II
city: Roma
country: Italy
facility: Policlinico Umberto I, Università La Sapienza
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Città della Salute e delle Scienza
city: Torino
country: Italy
facility: Ospedale San Luigi di Orbassano - Ospedale Mauriziano
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria Friuli Centrale
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
city: Viterbo
country: Italy
facility: Ospedale Belcolle
Study officials:
References: