Actively Recruiting
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
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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
Eligibility Criteria
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
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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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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