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