Clinical trial · Observational
Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY).
Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will ultimately aim at developing a GIMEMA platform for collecting HRQoL and symptom burden information on Italian patients with Philadelphia chromosome negative MPN. The main objective of the protocol is to improve our understanding of the impact of the disease and various treatments on patients-wellbeing, symptom burden and daily functioning.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
- timeFrame
- After 5 years from study entry
- description
- To detect a baseline difference of at least 4 points between MPN patients and their peers in the general population in any of the following primary scales of the EORTC QLQ-C30 questionnaire: fatigue, global QoL/health status, physical, emotional and role functioning (all ranging from 0 to 100 points).
Secondary outcomes (10)
- measure
- Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
- timeFrame
- After 5 years from study entry
- description
- The same comparisons described for the primary endpoint will be performed on all other scales from EORTC QLQ-C30 questionnaire.
- measure
- Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (pre-PMF, overt-PMF) and post-ET/post-PV Myelofibrosis (MF), (i.e. Philadelphia chromosome negative myeloproliferative neoplasm (MPN)) according to 2016 WHO classification. * Known IPSS/IPSET/DIPSS risk score category at time of initial diagnosis of PV, ET and PMF, respectively. * Initial diagnosis of MPN within one year before date of registration. * Having a full baseline PRO Evaluation completed. * Adult patients (≥ 18 years old). * Written informed consent provided. Exclusion Criteria: * Having any kind of psychiatric disorder or major cognitive dysfunction problems hampering a self-reported evaluation. * Not able to read and understand local language (i.e. Italian).
References
Publications (0)
Data not yet available