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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05553873
Other study ID # INFLA-ME
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2022
Est. completion date December 2026

Study information

Verified date December 2023
Source University of Milano Bicocca
Contact Elena Maria Elli
Phone 0392339859
Email elena.elli@libero.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Locations

Country Name City State
Italy Azienda Ospedaliera Universitaria Consorziale Policlinico Bari
Italy Policlinico Sant'Orsola Malpighi Bologna
Italy ASST Spedali Civili di Brescia Brescia
Italy Policlinico Vittorio Emanuele Catania
Italy Ospedale Universitario Federico II Napoli
Italy Policlinico Umberto I, Università La Sapienza Roma
Italy Azienda Ospedaliera Universitaria Città della Salute e delle Scienza Torino
Italy Ospedale San Luigi di Orbassano - Ospedale Mauriziano Torino
Italy Azienda Ospedaliera Universitaria Friuli Centrale Udine
Italy Azienda Ospedaliera Universitaria Integrata Verona
Italy Ospedale Belcolle Viterbo

Sponsors (1)

Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary CBC with leukocyte formula and calculation of the NLR and PLR ratio 60 months
Primary Occurrence of arterial and venous thrombotic events type of event, time to event after diagnosis, during illness 60 months
Secondary 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) 60 months
Secondary Time to thrombo-haemorrhagic events 60 months
Secondary Time to death and been alive at the end of the study 60 months
Secondary Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase 60 months
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