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NCT Number: NCT02808858

Italian Network MDS Registry

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

Recruiting

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Key information

Conditions

Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–106 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ematologia, AO SS. Antonio e Biagio, Alessandria, AL, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New diagnosis of MDS

Exclusion criteria

  • Patient who refuse the signature of informed consent

Treatment and study plan

Primary outcomes

  1. Incidence of MDS diagnosis

    Time frame: 6 years

    Number of new cases every 100.000 person/year

  2. 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

  3. Prevalence of MDS

    Time frame: 6 years

    Number of cases every 100.000 person

  4. Overall survival

    Time frame: 6 years

    Time between MDS diagnosis and death due to any causes

  5. Progression free survival

    Time frame: 6 years

    Time between MDS diagnosis and relapse/ progression or death due to any causes

  6. Progression to AML

    Time frame: 6 years

    Time between MDS diagnosis and Progression to AML or death due to any causes

Study contacts

Contact information is provided by the study sponsor or research team.

Segreteria FISM

CONTACT

[email protected]

013120 ext. 6066

Valeria Santini, Prof.

CONTACT

[email protected]

013120 ext. 6066

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Sindromi Mielodisplastiche-ETS

Other

Registry information

Official study title

Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)

Acronym: FISM_registry

Important dates

Study start
2013
Primary completion
2016
Study completion
2032
First posted
Jun 22, 2016
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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