Trial 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.
NCT ID:
NCT05553873
Condition:
Myeloproliferative Disease
Inflammatory Markers
Conditions: Official terms:
Neoplasms
Myeloproliferative Disorders
Inflammation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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
Criteria for eligibility:
Study pop:
Adults diagnosed with PV, ET, PMF or post PV and post ET MF, according to current WHO or
IWG-MRT criteria (diagnosis since 2000)
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda Ospedaliera Universitaria Consorziale Policlinico
Address:
City:
Bari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pellegrino Musto
Email:
pellegrino.musto@uniba.it
Facility:
Name:
Policlinico Sant'Orsola Malpighi
Address:
City:
Bologna
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesca Palandri
Email:
francesca.palandri@unibo.it
Facility:
Name:
ASST Spedali Civili di Brescia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Nicola Polverelli
Email:
nicola.polverelli@gmail.com
Facility:
Name:
Policlinico Vittorio Emanuele
Address:
City:
Catania
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Alberto Palumbo
Email:
palumbo.giuseppealberto@gmail.com
Facility:
Name:
Ospedale Universitario Federico II
Address:
City:
Napoli
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Novella Pugliese
Email:
novypugliese@yahoo.it
Facility:
Name:
Policlinico Umberto I, Università La Sapienza
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Massimo Breccia
Facility:
Name:
Azienda Ospedaliera Universitaria Città della Salute e delle Scienza
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giulia Benevolo
Email:
gbenevolo@cittadellasalute.to.it
Facility:
Name:
Ospedale San Luigi di Orbassano - Ospedale Mauriziano
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniela Cilloni
Email:
daniela.cilloni@unito.it
Facility:
Name:
Azienda Ospedaliera Universitaria Friuli Centrale
Address:
City:
Udine
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mario Tiribelli
Email:
mario.tiribelli@uniud.it
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Massimiliano Bonifacio
Email:
massimiliano.bonifacio@univr.it
Facility:
Name:
Ospedale Belcolle
Address:
City:
Viterbo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberto Latagliata
Email:
rob.lati@libero.it
Start date:
September 8, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
University of Milano Bicocca
Agency class:
Other
Source:
University of Milano Bicocca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05553873
