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Recruiting NCT02808858

Italian Network MDS Registry

Observational Myelodysplastic-Myeloproliferative Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Myelodysplastic-Myeloproliferative Diseases. Basic parameters: 18 years — 106 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)

Overview

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.

Primary outcome measures

  • Incidence of MDS diagnosis [Time frame: 6 years]
  • Overall Response rate [Time frame: 6 years]
  • Prevalence of MDS [Time frame: 6 years]
  • Overall survival [Time frame: 6 years]
  • Progression free survival [Time frame: 6 years]
  • Progression to AML [Time frame: 6 years]

Eligibility criteria

Inclusion criteria

  • New diagnosis of MDS

Exclusion criteria

  • Patient who refuse the signature of informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 20 centers
  • Ematologia, AO SS. Antonio e Biagio — Alessandria
  • Clinica di Ematologia, AOU Ospedale di Torrette — Ancona
  • U.O. Clinica Medicina Interna, IRCCS San Martino IST — Genova
  • Struttura Cattedra di Ematologia e CTMO, AOU di Parma — Parma
  • Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata — Rionero in Vulture
  • FPO - IRCCS di Candiolo — Candiolo
  • S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano — Torino
  • Ospedale Cardinal Massaia — Asti
  • … and 12 more centers

Identifiers

NCT: NCT02808858 · Rete italiana registri MDS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗