Italian Network MDS Registry

Myelodysplastic-Myeloproliferative Diseases Clinical Trial

— FISM_registry  

Official title:

Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02808858
• Other study ID #: Rete italiana registri MDS
• Status: Recruiting
• Start date: September 2013
• Est. completion date: May 2032

Study information

• Verified date: February 2024
• Source: Fondazione Italiana Sindromi Mielodisplastiche-ETS
• Contact: Valeria Santini, Prof.
• Phone: 013120
• Email: segreteriafismonlus[@]ospedale.al.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 2032
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 106 Years

Eligibility

Inclusion Criteria:

• New diagnosis of MDS

Exclusion Criteria:

• Patient who refuse the signature of informed consent

Related Conditions & MeSH terms

• Myelodysplastic-Myeloproliferative Diseases
• Myeloproliferative Disorders

Locations

Country	Name	City	State
Italy	Ematologia, AO SS. Antonio e Biagio	Alessandria	AL
Italy	Clinica di Ematologia, AOU Ospedale di Torrette	Ancona	AN
Italy	Ospedale Cardinal Massaia	Asti
Italy	Ematologia AOU Policlinico di Bari	Bari
Italy	Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola	Bologna
Italy	Ematologia- Ospedale Businco	Cagliari
Italy	FPO - IRCCS di Candiolo	Candiolo	Torino
Italy	Ospedale Maggiore	Chieri
Italy	Cattedra di Ematologia Policlino Careggi	Firenze
Italy	Dipartimento Emato-Oncologia AOU San Martino Genova	Genova
Italy	U.O. Clinica Medicina Interna, IRCCS San Martino IST	Genova	GE
Italy	Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga	Orbassano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Struttura Cattedra di Ematologia e CTMO, AOU di Parma	Parma	PR
Italy	Azienda Ospedaliera Perugia	Perugia
Italy	AOU San Salvatore	Pesaro
Italy	Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata	Rionero in Vulture	PZ
Italy	Ospedale San Giovanbni Battista-Molinette	Torino
Italy	S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano	Torino	TO
Italy	Divisione di Ematologia-Ospedale Cardinale Panico	Tricase

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Sindromi Mielodisplastiche-ETS

Country where clinical trial is conducted

Italy, 

Outcome

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