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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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