Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY).
PROPHECY
1 other identifier
observational
572
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Start
First participant enrolled
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2025
CompletedSeptember 23, 2025
September 1, 2025
3.5 years
April 28, 2020
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
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).
After 5 years from study entry
Secondary Outcomes (10)
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
After 5 years from study entry
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
After 5 years from study entry
MPN patients' baseline profiles of self-reported HRQoL
After 5 years from study entry
Prognostic value of baseline patients' self-reported fatigue
After 5 years from study entry
Prognostic value of baseline patients' self-reported HRQoL
After 5 years from study entry
- +5 more secondary outcomes
Interventions
Quality of life assessment
Eligibility Criteria
Adult patients with myeloproliferative neoplasms (MPN)
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
Asti, Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
Bari, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli"
Bologna, Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari, Italy
Aou Careggi - Firenze - Sod Ematologia
Florence, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan, Italy
Aou Di Modena - Sc Ematologia
Modena, Italy
Azienda Ospedaliera "S.Gerardo"
Monza, Italy
Aou Federico Ii - Napoli - Uoc Ematologia
Napoli, Italy
.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo, Italy
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
Pavia, Italy
Aou Pisana - Uo Ematologia Universitaria
Pisa, Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini, Italy
C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia
Rionero in Vulture, Italy
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, Italy
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, Italy
Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
Torino, Italy
Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
Torino, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2020
First Posted
May 7, 2020
Study Start
May 29, 2020
Primary Completion
November 15, 2023
Study Completion
November 15, 2025
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share