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.

Recruiting

• Conditions: Myeloproliferative Disease; Inflammatory Markers

• Registration Number: NCT05553873
• Lead Sponsor: University of Milano Bicocca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-08
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CBC with leukocyte formula and calculation of the NLR and PLR ratio	60 months
Occurrence of arterial and venous thrombotic events	60 months	type of event, time to event after diagnosis, during illness

Secondary Outcome Measures

Name	Time	Method
Time to thrombo-haemorrhagic events	60 months
Measurement of new and conventional inflammatory biomarkers	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)
Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase	60 months
Time to death and been alive at the end of the study	60 months

Trial Locations

Locations (11)

Policlinico Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Policlinico Umberto I, Università La Sapienza; 🇮🇹 Roma, Italy

Ospedale San Luigi di Orbassano - Ospedale Mauriziano; 🇮🇹 Torino, Italy

Policlinico Vittorio Emanuele; 🇮🇹 Catania, Italy

Azienda Ospedaliera Universitaria Friuli Centrale; 🇮🇹 Udine, Italy

Ospedale Universitario Federico II; 🇮🇹 Napoli, Italy

Ospedale Belcolle; 🇮🇹 Viterbo, Italy

Azienda Ospedaliera Universitaria Consorziale Policlinico; 🇮🇹 Bari, Italy

Azienda Ospedaliera Universitaria Città della Salute e delle Scienza; 🇮🇹 Torino, Italy

Azienda Ospedaliera Universitaria Integrata; 🇮🇹 Verona, Italy