Inflammatory Markers Clinical Trial
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.
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 |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
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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