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.

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553873
• Other study ID #: INFLA-ME
• Status: Recruiting
• Start date: September 8, 2022
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: University of Milano Bicocca
• Contact: Elena Maria Elli
• Phone: 0392339859
• Email: elena.elli[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Markers
• Myeloproliferative Disease
• Myeloproliferative Disorders
• Neoplasms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

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