Clinical trial NCT02808858: Italian Network MDS Registry
Official title: Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelodysplastic-Myeloproliferative Diseases
Keywords: MDS
Myelodisplastic Syndrome
Lead sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 106
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with new diagnosis of MDS

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

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.

Eligibility criteria: Inclusion Criteria:

* New diagnosis of MDS

Exclusion Criteria:

* Patient who refuse the signature of informed consent

Primary outcomes:
measure: Incidence of MDS diagnosis
timeFrame: 6 years
measure: Overall Response rate
timeFrame: 6 years
measure: Prevalence of MDS
timeFrame: 6 years
measure: Overall survival
timeFrame: 6 years
measure: Progression free survival
timeFrame: 6 years
measure: Progression to AML
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ematologia, AO SS. Antonio e Biagio
state: AL
city: Ancona
country: Italy
facility: Clinica di Ematologia, AOU Ospedale di Torrette
state: AN
city: Genova
country: Italy
facility: U.O. Clinica Medicina Interna, IRCCS San Martino IST
state: GE
city: Parma
country: Italy
facility: Struttura Cattedra di Ematologia e CTMO, AOU di Parma
state: PR
city: Rionero in Vulture
country: Italy
facility: Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata
state: PZ
city: Candiolo
country: Italy
facility: FPO - IRCCS di Candiolo
state: Torino
city: Torino
country: Italy
facility: S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano
state: TO
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Bari
country: Italy
facility: Ematologia AOU Policlinico di Bari
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
city: Cagliari
country: Italy
facility: Ematologia- Ospedale Businco
city: Chieri
country: Italy
facility: Ospedale Maggiore
city: Firenze
country: Italy
facility: Cattedra di Ematologia Policlino Careggi
city: Genova
country: Italy
facility: Dipartimento Emato-Oncologia AOU San Martino Genova
city: Orbassano
country: Italy
facility: Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Perugia
country: Italy
facility: Azienda Ospedaliera Perugia
city: Pesaro
country: Italy
facility: AOU San Salvatore
city: Torino
country: Italy
facility: Ospedale San Giovanbni Battista-Molinette
city: Tricase
country: Italy
facility: Divisione di Ematologia-Ospedale Cardinale Panico
Study officials:
References: