Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY). (PROPHECY)

September 17, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

572

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
      • Asti, Italy
        • Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
      • Bari, Italy
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
      • Bari, Italy
        • Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
      • Bologna, Italy
        • Istituto di Ematologia "Lorenzo e A. Seragnoli"
      • Cagliari, Italy
        • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
      • Florence, Italy
        • Aou Careggi - Firenze - Sod Ematologia
      • Milan, Italy
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
      • Modena, Italy
        • Aou Di Modena - Sc Ematologia
      • Monza, Italy
        • Azienda Ospedaliera "S.Gerardo"
      • Napoli, Italy
        • Aou Federico Ii - Napoli - Uoc Ematologia
      • Novara, Italy
        • .C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
      • Palermo, Italy
        • Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
      • Pavia, Italy
        • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
      • Pisa, Italy
        • Aou Pisana - Uo Ematologia Universitaria
      • Reggio Emilia, Italy
        • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
      • Rimini, Italy
        • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
      • Rionero in Vulture, Italy
        • C.R.O.B. - I.R.C.C.S. - Rionero in Volture - 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
        • Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
      • Sassari, Italy
        • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
      • Torino, Italy
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
      • Torino, Italy
        • Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
      • Torino, Italy
        • Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with myeloproliferative neoplasms (MPN)

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
Time Frame: After 5 years from study entry
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
Time Frame: After 5 years from study entry
The same comparisons described for the primary endpoint will be performed on all other scales from EORTC QLQ-C30 questionnaire.
After 5 years from study entry
Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population
Time Frame: After 5 years from study entry
The same comparisons described for the primary endpoint will be performed on all other scales from FACIT-Fatigue questionnaire.
After 5 years from study entry
MPN patients' baseline profiles of self-reported HRQoL
Time Frame: After 5 years from study entry
To report MPN patients' baseline profiles of self-reported HRQoL and symptoms scores.
After 5 years from study entry
Relationship between pruritus and HRQoL.
Time Frame: After 5 years from study entry
To investigate the relationship between Pruritus as assessed by MPN-SAF TSS questionnaire and HRQoL.
After 5 years from study entry
Patterns over time of HRQoL
Time Frame: After 5 years from study entry
To estimate and compare patterns over time of HRQoL (outcome measures: EORTC QLQ-C30, FACIT-Fatigue, MPN-SAF TSS and FACIT-TS-G) of PT, EV and PMF patients.
After 5 years from study entry
Prognostic patient-based index
Time Frame: After 5 years from study entry
To devise a prognostic patient-based index.
After 5 years from study entry
Physicians' and patients' preferences for involvement in treatment decision-making
Time Frame: After 5 years from study entry
To assess physicians' and patients' preferences for involvement in treatment decision-making, as assessed by the CPS Questionnaire, across different risk groups and examine relationships between preferences for involvement and patient characteristics.
After 5 years from study entry
Relationship between self-reported satisfaction with care with other HRQoL outcomes.
Time Frame: After 5 years from study entry
To investigate the relationship, in MPN patients, between self-reported satisfaction with care as assessed by the FACIT-TS-G questionnaire and its relationship with other HRQoL outcomes.
After 5 years from study entry
Prognostic value of baseline patients' self-reported fatigue
Time Frame: After 5 years from study entry
To investigate the prognostic value of baseline patients' self-reported fatigue from EORTC QLQ-C30
After 5 years from study entry
Prognostic value of baseline patients' self-reported HRQoL
Time Frame: After 5 years from study entry
To investigate the prognostic value of baseline patients' self-reported HRQoL
After 5 years from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2020

Primary Completion (Actual)

November 15, 2023

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIMEMA QoL-MPN 0118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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