Italian Network MDS Registry

Recruiting

• Conditions: Myelodysplastic-Myeloproliferative Diseases

• Registration Number: NCT02808858
• Lead Sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2016-05-18
• Primary Completion: 2016-06
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Study Completion: 2032-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• New diagnosis of MDS

Exclusion Criteria

• Patient who refuse the signature of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (20)

AOU San Salvatore; 🇮🇹 Pesaro, Italy

Dipartimento Emato-Oncologia AOU San Martino Genova; 🇮🇹 Genova, Italy

Azienda Ospedaliera Perugia; 🇮🇹 Perugia, Italy

Ematologia, AO SS. Antonio e Biagio; 🇮🇹 Alessandria, AL, Italy

Clinica di Ematologia, AOU Ospedale di Torrette; 🇮🇹 Ancona, AN, Italy

U.O. Clinica Medicina Interna, IRCCS San Martino IST; 🇮🇹 Genova, GE, Italy

Struttura Cattedra di Ematologia e CTMO, AOU di Parma; 🇮🇹 Parma, PR, Italy

Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata; 🇮🇹 Rionero in Vulture, PZ, Italy

FPO - IRCCS di Candiolo; 🇮🇹 Candiolo, Torino, Italy

S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano; 🇮🇹 Torino, TO, 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

Ospedale Maggiore; 🇮🇹 Chieri, Italy

Cattedra di Ematologia Policlino Careggi; 🇮🇹 Firenze, Italy

Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga; 🇮🇹 Orbassano, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Ospedale San Giovanbni Battista-Molinette; 🇮🇹 Torino, Italy

Divisione di Ematologia-Ospedale Cardinale Panico; 🇮🇹 Tricase, Italy