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 ID: NCT05553873

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-08

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Myeloproliferative Disease Inflammatory Markers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedaliera Universitaria Consorziale Policlinico

Bari, , Italy

Site Status RECRUITING

Policlinico Sant'Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

ASST Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

Policlinico Vittorio Emanuele

Catania, , Italy

Site Status RECRUITING

Ospedale Universitario Federico II

Napoli, , Italy

Site Status RECRUITING

Policlinico Umberto I, Università La Sapienza

Roma, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Città della Salute e delle Scienza

Torino, , Italy

Site Status RECRUITING

Ospedale San Luigi di Orbassano - Ospedale Mauriziano

Torino, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Friuli Centrale

Udine, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Site Status RECRUITING

Ospedale Belcolle

Viterbo, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Maria Elli

Role: CONTACT

0392339859

Benedetta Valeri

Role: CONTACT

Facility Contacts

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Pellegrino Musto

Role: primary

Francesca Palandri

Role: primary

Nicola Polverelli

Role: primary

Giuseppe Alberto Palumbo

Role: primary

Novella Pugliese

Role: primary

Massimo Breccia

Role: primary

Giulia Benevolo

Role: primary

Daniela Cilloni

Role: primary

Mario Tiribelli

Role: primary

Massimiliano Bonifacio

Role: primary

Roberto Latagliata

Role: primary

Other Identifiers

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INFLA-ME

Identifier Type: -

Identifier Source: org_study_id

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