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.
1 other identifier
observational
500
1 country
11
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2022
CompletedFirst Submitted
Initial submission to the registry
September 21, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 2, 2024
December 1, 2023
4.2 years
September 21, 2022
December 29, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
CBC with leukocyte formula and calculation of the NLR and PLR ratio
60 months
Occurrence of arterial and venous thrombotic events
type of event, time to event after diagnosis, during illness
60 months
Secondary Outcomes (4)
Measurement of new and conventional inflammatory biomarkers
60 months
Time to thrombo-haemorrhagic events
60 months
Time to death and been alive at the end of the study
60 months
Time to evolution of the PH negative MPN disease into the fibrotic, accelerated or leukemic phase
60 months
Eligibility Criteria
Adults diagnosed with PV, ET, PMF or post PV and post ET MF, according to current WHO or IWG-MRT criteria (diagnosis since 2000)
You may qualify if:
- 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
You may not qualify if:
- Life expectancy of less than 6 months
- Accelerated phase myelofibrosis or MPN with signs of leukemic evolution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Azienda Ospedaliera Universitaria Consorziale Policlinico
Bari, Italy
Policlinico Sant'Orsola Malpighi
Bologna, Italy
ASST Spedali Civili di Brescia
Brescia, Italy
Policlinico Vittorio Emanuele
Catania, Italy
Ospedale Universitario Federico II
Napoli, Italy
Policlinico Umberto I, Università La Sapienza
Roma, Italy
Azienda Ospedaliera Universitaria Città della Salute e delle Scienza
Torino, Italy
Ospedale San Luigi di Orbassano - Ospedale Mauriziano
Torino, Italy
Azienda Ospedaliera Universitaria Friuli Centrale
Udine, Italy
Azienda Ospedaliera Universitaria Integrata
Verona, Italy
Ospedale Belcolle
Viterbo, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2022
First Posted
September 23, 2022
Study Start
September 8, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 2, 2024
Record last verified: 2023-12