Actively Recruiting

Age: 18Years - 99Years
All Genders
ID05553873

Evaluation of Inflammatory Markers in Philadelphia Negative Myeloproliferative Neoplasms: Impact on Outcome and Response to Therapy

Led by University of Milano Bicocca · Updated on 2024-01-02

500

Participants Needed

11

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with Philadelphia chromosome-negative Myeloproliferative Neoplasms (MPN Ph negative) to observe inflammatory biomarkers and track their changes over the course of the disease. The study aims to find links between these biomarkers and important disease outcomes such as blood clots, bleeding events, and progression to more severe disease stages like accelerated or blast phases. This observational study is designed to improve risk assessment for patients with these blood disorders. This study is observational and does not involve experimental treatments. It gathers data on inflammatory markers and clinical events in patients diagnosed with types of MPN including polycythemia vera, essential thrombocythemia, primary myelofibrosis, and post-PV or post-ET myelofibrosis. The study collects information retrospectively and prospectively from medical records and laboratory tests over a period of up to 60 months (5 years). Participants will be monitored through routine blood counts with white cell formulas to calculate inflammatory ratios, along with tracking arterial and venous thrombotic events. The study also measures conventional and new inflammatory biomarkers, time to thrombo-hemorrhagic events, survival status, and disease progression to fibrotic, accelerated, or leukemic phases. The total observation period is planned for 60 months, and participants provide informed consent to share their data for this research.

CONDITIONS

Brief 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.

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of diagnosis of MPN Ph negative
  • Diagnosis of polycythemia vera, essential thrombocythemia, primary myelofibrosis, or post-PV/post-ET myelofibrosis according to current WHO or IWG-MRT criteria since 2000
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Life expectancy less than 6 months
  • Presence of accelerated phase myelofibrosis or signs of leukemic evolution of MPN

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Up to 60 months

Participants are observed over time with regular blood tests and clinical assessments to evaluate inflammatory markers, thrombotic events, and disease progression.

Periodic visits over 60 months

Trial Site Locations

Total: 11 locations

1

Azienda Ospedaliera Universitaria Consorziale Policlinico

Bari, Italy

Actively Recruiting

2

Policlinico Sant'Orsola Malpighi

Bologna, Italy

Actively Recruiting

3

ASST Spedali Civili di Brescia

Brescia, Italy

Actively Recruiting

4

Policlinico Vittorio Emanuele

Catania, Italy

Actively Recruiting

5

Ospedale Universitario Federico II

Naples, Italy

Actively Recruiting

6

Policlinico Umberto I, Università La Sapienza

Roma, Italy

Actively Recruiting

7

Azienda Ospedaliera Universitaria Città della Salute e delle Scienza

Torino, Italy

Actively Recruiting

8

Ospedale San Luigi di Orbassano - Ospedale Mauriziano

Torino, Italy

Actively Recruiting

9

Azienda Ospedaliera Universitaria Friuli Centrale

Udine, Italy

Actively Recruiting

10

Azienda Ospedaliera Universitaria Integrata

Verona, Italy

Actively Recruiting

11

Ospedale Belcolle

Viterbo, Italy

Actively Recruiting

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Research Team

E

Elena Maria Elli

B

Benedetta Valeri

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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