Italian Network MDS Registry (FISM_registry)

February 14, 2024 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
        • 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
      • Firenze, 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

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)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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