Evaluating inflammatory markers in patients with certain blood disorders
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.
This study looks at patients with specific blood disorders to see if certain inflammation markers can help predict how their disease will progress and their risk of complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 11 sites (Bari and 10 other locations) |
| Trial ID | NCT05553873 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Philadelphia chromosome-negative myeloproliferative neoplasms (MPN) to assess inflammatory biomarkers and their trends over the course of the disease. It aims to identify correlations between these biomarkers and disease outcomes, particularly regarding thrombo-haemorrhagic events and disease progression. By analyzing historical data, the study seeks to enhance risk stratification and improve patient management strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with Philadelphia chromosome-negative MPN such as polycythemia vera, essential thrombocythemia, or primary myelofibrosis.
Not a fit: Patients with a life expectancy of less than 6 months or those in an accelerated phase of myelofibrosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and treatment strategies for patients with myeloproliferative neoplasms.
How similar studies have performed: While this study explores a specific aspect of myeloproliferative neoplasms, similar studies have shown promise in understanding the role of inflammatory markers in various diseases, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bari and 10 other locations
- Azienda Ospedaliera Universitaria Consorziale Policlinico — Bari, Italy (Recruiting)
- Policlinico Sant'Orsola Malpighi — Bologna, Italy (Recruiting)
- ASST Spedali Civili di Brescia — Brescia, Italy (Recruiting)
- Policlinico Vittorio Emanuele — Catania, Italy (Recruiting)
- Ospedale Universitario Federico II — Naples, Italy (Recruiting)
- Policlinico Umberto I, Università La Sapienza — Roma, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Città della Salute e delle Scienza — Torino, Italy (Recruiting)
- Ospedale San Luigi di Orbassano - Ospedale Mauriziano — Torino, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Friuli Centrale — Udine, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Integrata — Verona, Italy (Recruiting)
- Ospedale Belcolle — Viterbo, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Maria Elli
- Email: elena.elli@libero.it
- Phone: 0392339859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.