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Myelodysplastic-Myeloproliferative DiseasesFISM_registryNCT02808858

Italian Network MDS Registry

An observational study of Myelodysplastic-Myeloproliferative Diseases, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 20 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS) newly diagnosed. Read more about this study

Who is it for?
Ages 18 to 106 years
How many people
10,000 participants
Where
20 sitesItaly
Study dates
Sep 2013to May 2032
How long will I take part?
10 Years
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 to 106 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with new diagnosis of MDS

Who may be able to join

  • New diagnosis of MDS

Who cannot join

  • Patient who refuse the signature of informed consent

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Valeria Santini, Prof. contact

013120 ext. 6066

segreteriafismonlus@ospedale.al.it

Segreteria FISM contact

013120 ext. 6066

segreteriafismonlus@ospedale.al.it

20 sites in 1 country

Italy20 sites, 20 recruiting

  • Ematologia, AO SS. Antonio e Biagio

    Alessandria, AL, 15121

    Flavia Salvi, MD, +39 0131206066, fsalvi@ospedale.al.it

    Flavia Salvi, MD

    Recruiting

  • Clinica di Ematologia, AOU Ospedale di Torrette

    Ancona, AN, 60020

    Antonella Poloni, MD, a.poloni@univpm.it

    Antonella Poloni, MD

    Recruiting

  • Ospedale Cardinal Massaia

    Asti

    Giorgio Ciravegna, MD

    Recruiting

  • Ematologia AOU Policlinico di Bari

    Bari, 70124

    Giorgina Specchia, Professor

    Recruiting

  • Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola

    Bologna, 40100

    Carlo Finelli, Professor

    Recruiting

  • Ematologia- Ospedale Businco

    Cagliari, 09121

    Emanuele Angelucci, MD

    Recruiting

  • FPO - IRCCS di Candiolo

    Candiolo, Torino, 10060

    Elena Crisà, MD, 0119933250, elena.cris@ircc.it

    Recruiting

  • Ospedale Maggiore

    Chieri

    Gianni Cametti, MD

    Recruiting

  • Cattedra di Ematologia Policlino Careggi

    Florence, 50134

    Valeria Santini, Professor

    Recruiting

  • U.O. Clinica Medicina Interna, IRCCS San Martino IST

    Genova, GE, 16132

    Enrico Balleari, MD, +39 010 5555784, balleari@unige.it

    Enrico Balleari, MD

    Recruiting

  • Dipartimento Emato-Oncologia AOU San Martino Genova

    Genova, 16132

    Riccardo Ghio, MD

    Recruiting

  • Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga

    Orbassano, 10043

    Giuseppe Saglio, Professor

    Recruiting

  • Azienda Ospedaliera di Padova

    Padova, 35128

    Giampiero Semenzato, MD

    Recruiting

  • Struttura Cattedra di Ematologia e CTMO, AOU di Parma

    Parma, PR, 43100

    Monica Crugnola, MD, +39 0521-702494, mo@vodafone.it

    +39 0521-70

    Recruiting

  • Azienda Ospedaliera Perugia

    Perugia

    Anna Maria Liberati, MD

    Recruiting

  • AOU San Salvatore

    Pesaro, 61122

    Giuseppe Visani, MD

    Recruiting

  • Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata

    Rionero in Vulture, PZ, 85028

    Pellegrino Musto, MD

    Recruiting

  • S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano

    Torino, TO, 10128

    Corrado Tarella, Prof.

    Recruiting

  • Ospedale San Giovanbni Battista-Molinette

    Torino

    Umberto Vitolo, MD

    Recruiting

  • Divisione di Ematologia-Ospedale Cardinale Panico

    Tricase, 73039

    Vincenzo Pavone, MD

    Recruiting

Other trials in Italy

About this study

Official title: Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)

Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS) newly diagnosed.

Read the detailed description

Development of an Italian regional registries MDS network using the same electronic case report form for data storage, with the following broad aims:

  • Ability to aggregate and process anonymous epidemiological data collected by individual regional registers;
  • Ability to aggregate the available data with those of other international registries existing.
Keywords
MDS, Myelodisplastic Syndrome
Medical subject headings
Myelodysplastic-Myeloproliferative Diseases

What is being measured

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

  1. Incidence of MDS diagnosis

    Number of new cases every 100.000 person/year

    Measured: 6 years

  2. Overall Response rate

    Proportion of CR or PR after each line of treatment in term of erythroid, platelet and granulocyte response

    Measured: 6 years

  3. Prevalence of MDS

    Number of cases every 100.000 person

    Measured: 6 years

  4. Overall survival

    Time between MDS diagnosis and death due to any causes

    Measured: 6 years

  5. Progression free survival

    Time between MDS diagnosis and relapse/ progression or death due to any causes

    Measured: 6 years

  6. Progression to AML

    Time between MDS diagnosis and Progression to AML or death due to any causes

    Measured: 6 years

Timeline

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

  1. First posted22 Jun 2016 (estimated)
  2. Study startSep 2013
  3. Primary completionJun 2016
  4. Study completionMay 2032 (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
Case only
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02808858
Sponsor's protocol ID
Rete italiana registri MDS
Acronym
FISM_registry
Status last verified
Sep 2026
First submitted
18 May 2016
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myelodysplastic-Myeloproliferative Diseases, run by Fondazione Italiana Sindromi Mielodisplastiche-ETS at 20 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

Contact Valeria Santini, Prof. (013120 ext. 6066, segreteriafismonlus@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of MDS diagnosis (time frame: 6 years). The study lists 6 primary outcomes in all. 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 NCT02808858.

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 4 Sep 2026.

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