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NCT Number: 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.

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

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Key information

Conditions

Myeloproliferative Disease Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Inflammatory Markers Myeloproliferative Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Consorziale Policlinico, Bari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CBC with leukocyte formula and calculation of the NLR and PLR ratio

    Time frame: 60 months

  2. Occurrence of arterial and venous thrombotic events

    Time frame: 60 months

    type of event, time to event after diagnosis, during illness

Secondary outcomes

  1. Measurement of new and conventional inflammatory biomarkers

    Time frame: 60 months

    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)

  2. Time to thrombo-haemorrhagic events

    Time frame: 60 months

  3. Time to death and been alive at the end of the study

    Time frame: 60 months

  4. Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase

    Time frame: 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Benedetta Valeri

CONTACT

[email protected]

Elena Maria Elli

CONTACT

[email protected]

0392339859

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2022
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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