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

NCT ID: NCT04378855

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

572 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-29

Study Completion Date

2025-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Myeloproliferative Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire

Quality of life assessment

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia

Alessandria, , Italy

Site Status

Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia

Asti, , Italy

Site Status

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

Bari, , Italy

Site Status

Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia

Bari, , Italy

Site Status

Istituto di Ematologia "Lorenzo e A. Seragnoli"

Bologna, , Italy

Site Status

Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo

Cagliari, , Italy

Site Status

Aou Careggi - Firenze - Sod Ematologia

Florence, , Italy

Site Status

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano

Milan, , Italy

Site Status

Aou Di Modena - Sc Ematologia

Modena, , Italy

Site Status

Azienda Ospedaliera "S.Gerardo"

Monza, , Italy

Site Status

Aou Federico Ii - Napoli - Uoc Ematologia

Napoli, , Italy

Site Status

.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro

Novara, , Italy

Site Status

Aou Policlinico P. Giaccone - Palermo - Uo Ematologia

Palermo, , Italy

Site Status

Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

Pavia, , Italy

Site Status

Aou Pisana - Uo Ematologia Universitaria

Pisa, , Italy

Site Status

Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia

Reggio Emilia, , Italy

Site Status

Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia

Rimini, , Italy

Site Status

C.R.O.B. - I.R.C.C.S. - Rionero in Volture - Uoc Ematologia

Rionero in Vulture, , Italy

Site Status

Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia

Roma, , Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, , Italy

Site Status

Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

Roma, , Italy

Site Status

Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia

Sassari, , Italy

Site Status

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

Torino, , Italy

Site Status

Asl to 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia

Torino, , Italy

Site Status

Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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GIMEMA QoL-MPN 0118

Identifier Type: -

Identifier Source: org_study_id

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