Italian Network MDS Registry (FISM_registry)

February 27, 2025 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

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

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 Backup

Study Locations

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

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

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

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

September 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimated)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rete italiana registri MDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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