AzTrials
AzTrials

Myeloproliferative NeoplasmPROPHECYNCT04378855

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

An observational study of Myeloproliferative Neoplasm, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 25 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloproliferative Neoplasm
What is being tested?
Questionnaire
How many people
572 participants
Where
25 sitesItaly
Study dates
29 May 2020to 15 Nov 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with myeloproliferative neoplasms (MPN)

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

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

    Alessandria

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

    Asti

  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

    Bari

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

    Bari

  • Istituto di Ematologia "Lorenzo e A. Seragnoli"

    Bologna

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

    Cagliari

  • Aou Careggi - Firenze - Sod Ematologia

    Florence

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

    Milan

  • Aou Di Modena - Sc Ematologia

    Modena

  • Azienda Ospedaliera "S.Gerardo"

    Monza

  • Aou Federico Ii - Napoli - Uoc Ematologia

    Naples

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

    Novara

  • Aou Policlinico P. Giaccone - Palermo - Uo Ematologia

    Palermo

  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

    Pavia

  • Aou Pisana - Uo Ematologia Universitaria

    Pisa

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

    Reggio Emilia

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

    Rimini

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

    Rionero in Vulture

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

    Roma

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

    Roma

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

    Roma

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

    Sassari

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

    Torino

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

    Torino

  • Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia

    Torino

Other trials in Italy

About this study

Official title: 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.

Being tested
Questionnaire
Medical subject headings
Myeloproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Quality of life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: After 5 years from study entry

Secondary outcomes (10)

  1. Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population

    The same comparisons described for the primary endpoint will be performed on all other scales from EORTC QLQ-C30 questionnaire.

    Measured: After 5 years from study entry

  2. Compare HRQoL profiles of Philadelphia chromosome negative MPN patients with those of their peers in the general population

    The same comparisons described for the primary endpoint will be performed on all other scales from FACIT-Fatigue questionnaire.

    Measured: After 5 years from study entry

  3. MPN patients' baseline profiles of self-reported HRQoL

    To report MPN patients' baseline profiles of self-reported HRQoL and symptoms scores.

    Measured: After 5 years from study entry

  4. Prognostic value of baseline patients' self-reported fatigue

    To investigate the prognostic value of baseline patients' self-reported fatigue from EORTC QLQ-C30

    Measured: After 5 years from study entry

  5. Prognostic value of baseline patients' self-reported HRQoL

    To investigate the prognostic value of baseline patients' self-reported HRQoL

    Measured: After 5 years from study entry

  6. Relationship between pruritus and HRQoL.

    To investigate the relationship between Pruritus as assessed by MPN-SAF TSS questionnaire and HRQoL.

    Measured: After 5 years from study entry

  7. Patterns over time of HRQoL

    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.

    Measured: After 5 years from study entry

  8. Prognostic patient-based index

    To devise a prognostic patient-based index.

    Measured: After 5 years from study entry

  9. Physicians' and patients' preferences for involvement in treatment decision-making

    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.

    Measured: After 5 years from study entry

  10. Relationship between self-reported satisfaction with care with other HRQoL outcomes.

    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.

    Measured: After 5 years from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start29 May 2020
  3. Primary completion15 Nov 2023
  4. Study completion15 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378855
Sponsor's protocol ID
GIMEMA QoL-MPN 0118
Acronym
PROPHECY
Status last verified
Sep 2025
First submitted
28 Apr 2020
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myeloproliferative Neoplasm, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04378855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in