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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myeloproliferative Disease, Inflammatory Markers. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- CBC with leukocyte formula and calculation of the NLR and PLR ratio [Time frame: 60 months]
- Occurrence of arterial and venous thrombotic events [Time frame: 60 months]
Secondary outcome measures (4)
- Measurement of new and conventional inflammatory biomarkers [Time frame: 60 months]
- Time to thrombo-haemorrhagic events [Time frame: 60 months]
- Time to death and been alive at the end of the study [Time frame: 60 months]
- Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase [Time frame: 60 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 11 centers
- Azienda Ospedaliera Universitaria Consorziale Policlinico — Bari
- Policlinico Sant'Orsola Malpighi — Bologna
- ASST Spedali Civili di Brescia — Brescia
- Policlinico Vittorio Emanuele — Catania
- Ospedale Universitario Federico II — Naples
- Policlinico Umberto I, Università La Sapienza — Roma
- Azienda Ospedaliera Universitaria Città della Salute e delle Scienza — Torino
- Ospedale San Luigi di Orbassano - Ospedale Mauriziano — Torino
- … and 3 more centers
Identifiers
NCT: NCT05553873 · INFLA-ME