Italian Network MDS Registry (FISM_registry)

September 2, 2026 updated by: Fondazione Italiana Sindromi Mielodisplastiche-ETS

Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.

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 (Estimated)

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.
10000

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Asti, Italy
        • Recruiting
        • Ospedale Cardinal Massaia
        • Principal Investigator:
          • Giorgio Ciravegna, MD
      • Bari, Italy, 70124
        • Recruiting
        • Ematologia AOU Policlinico di Bari
        • Principal Investigator:
          • Giorgina Specchia, Professor
      • Bologna, Italy, 40100
        • Recruiting
        • Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
        • Principal Investigator:
          • Carlo Finelli, Professor
      • Cagliari, Italy, 09121
        • Recruiting
        • Ematologia- Ospedale Businco
        • Principal Investigator:
          • Emanuele Angelucci, MD
      • Chieri, Italy
        • Recruiting
        • Ospedale Maggiore
        • Principal Investigator:
          • Gianni Cametti, MD
      • Florence, Italy, 50134
        • Recruiting
        • Cattedra di Ematologia Policlino Careggi
        • Principal Investigator:
          • Valeria Santini, Professor
      • Genova, Italy, 16132
        • Recruiting
        • Dipartimento Emato-Oncologia AOU San Martino Genova
        • Principal Investigator:
          • Riccardo Ghio, MD
      • Orbassano, Italy, 10043
        • Recruiting
        • Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
        • Principal Investigator:
          • Giuseppe Saglio, Professor
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera di Padova
        • Principal Investigator:
          • Giampiero Semenzato, MD
      • Perugia, Italy
        • Recruiting
        • Azienda Ospedaliera Perugia
        • Principal Investigator:
          • Anna Maria Liberati, MD
      • Pesaro, Italy, 61122
        • Recruiting
        • AOU San Salvatore
        • Principal Investigator:
          • Giuseppe Visani, MD
      • Torino, Italy
        • Recruiting
        • Ospedale San Giovanbni Battista-Molinette
        • Principal Investigator:
          • Umberto Vitolo, MD
      • Tricase, Italy, 73039
        • Recruiting
        • Divisione di Ematologia-Ospedale Cardinale Panico
        • Principal Investigator:
          • Vincenzo Pavone, MD
    • AL
      • Alessandria, AL, Italy, 15121
        • Recruiting
        • Ematologia, AO SS. Antonio e Biagio
        • Contact:
        • Principal Investigator:
          • Flavia Salvi, MD
    • AN
      • Ancona, AN, Italy, 60020
        • Recruiting
        • Clinica di Ematologia, AOU Ospedale di Torrette
        • Contact:
        • Principal Investigator:
          • Antonella Poloni, MD
    • GE
      • Genova, GE, Italy, 16132
        • Recruiting
        • U.O. Clinica Medicina Interna, IRCCS San Martino IST
        • Contact:
        • Principal Investigator:
          • Enrico Balleari, MD
    • PR
      • Parma, PR, Italy, 43100
        • Recruiting
        • Struttura Cattedra di Ematologia e CTMO, AOU di Parma
        • Contact:
          • Monica Crugnola, MD
          • Phone Number: +39 0521-702494
          • Email: mo@vodafone.it
        • Contact:
          • Phone Number: +39 0521-70
        • Principal Investigator:
          • Monica Crugnola, MD
    • PZ
      • Rionero in Vulture, PZ, Italy, 85028
        • Recruiting
        • Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata
        • Principal Investigator:
          • Pellegrino Musto, MD
    • TO
      • Torino, TO, Italy, 10128
        • Recruiting
        • S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano
        • Principal Investigator:
          • Corrado Tarella, Prof.
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • FPO - IRCCS di Candiolo
        • Contact:

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 to 106 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with new diagnosis of MDS

Description

Inclusion Criteria:

  • New diagnosis of MDS

Exclusion Criteria:

  • Patient who refuse the signature of informed consent

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
Incidence of MDS diagnosis
Time Frame: 6 years
Number of new cases every 100.000 person/year
6 years
Overall Response rate
Time Frame: 6 years
Proportion of CR or PR after each line of treatment in term of erythroid, platelet and granulocyte response
6 years
Prevalence of MDS
Time Frame: 6 years
Number of cases every 100.000 person
6 years
Overall survival
Time Frame: 6 years
Time between MDS diagnosis and death due to any causes
6 years
Progression free survival
Time Frame: 6 years
Time between MDS diagnosis and relapse/ progression or death due to any causes
6 years
Progression to AML
Time Frame: 6 years
Time between MDS diagnosis and Progression to AML or death due to any causes
6 years

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.
Fondazione Italiana Sindromi Mielodisplastiche-ETS

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.
September 1, 2013

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.
June 1, 2016

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.
May 1, 2032

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).
May 18, 2016

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.
June 17, 2016

First Posted (Estimated)

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.
June 22, 2016

Study Record Updates

Last Update Posted (Actual)

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 4, 2026

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 2, 2026

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, 2026

More Information

Terms related to this study

Keywords

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.
  • Rete italiana registri MDS

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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