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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05553873
Enrollment
500
Registered
2022-09-23
Start date
2022-09-08
Completion date
2026-12-31
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Markers, Myeloproliferative Disease

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

Interventions

None listed

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CBC with leukocyte formula and calculation of the NLR and PLR ratio60 months
Occurrence of arterial and venous thrombotic events60 monthstype of event, time to event after diagnosis, during illness

Secondary

MeasureTime frameDescription
Measurement of new and conventional inflammatory biomarkers60 monthsat 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 to thrombo-haemorrhagic events60 months
Time to death and been alive at the end of the study60 months
Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase60 months

Countries

Italy

Contacts

Primary ContactElena Maria Elli
elena.elli@libero.it0392339859
Backup ContactBenedetta Valeri
benedettavalerihsg@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026