Clinical Trial: Italian Network MDS Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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

Detailed Summary:

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.

Sponsor: Fondazione Italiana Sindromi Mielodisplastiche Onlus

Current Primary Outcome:

  • Incidence of MDS diagnosis [ Time Frame: 6 years ]
    Number of new cases every 100.000 person/year
  • 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
  • Prevalence of MDS [ Time Frame: 6 years ]
    Number of cases every 100.000 person
  • Overall survival [ Time Frame: 6 years ]
    Time between MDS diagnosis and death due to any causes
  • Progression free survival [ Time Frame: 6 years ]
    Time between MDS diagnosis and relapse/ progression or death due to any causes
  • Progression to AML [ Time Frame: 6 years ]
    Time between MDS diagnosis and Progression to AML or death due to any causes


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fondazione Italiana Sindromi Mielodisplastiche Onlus

Dates:
Date Received: May 18, 2016
Date Started: September 2013
Date Completion: May 2020
Last Updated: June 17, 2016
Last Verified: May 2016