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Italian Network MDS Registry (FISM_registry)

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ClinicalTrials.gov Identifier: NCT02808858
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Sindromi Mielodisplastiche Onlus

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

Condition or disease
Myelodysplastic-Myeloproliferative Diseases

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 Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)
Study Start Date : September 2013
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : May 2020





Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 106 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with new diagnosis of MDS
Criteria

Inclusion Criteria:

  • New diagnosis of MDS

Exclusion Criteria:

  • Patient who refuse the signature of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808858


Contacts
Contact: Valeria Santini, Prof. 013120 ext 6066 segreteriafismonlus@ospedale.al.it
Contact: Segreteria FISM 013120 ext 6066 segreteriafismonlus@ospedale.al.it

Locations
Italy
Ematologia, AO SS. Antonio e Biagio Recruiting
Alessandria, AL, Italy, 15121
Contact: Flavia Salvi, MD    +39 0131206066    fsalvi@ospedale.al.it   
Principal Investigator: Flavia Salvi, MD         
Clinica di Ematologia, AOU Ospedale di Torrette Recruiting
Ancona, AN, Italy, 60020
Contact: Antonella Poloni, MD       a.poloni@univpm.it   
Principal Investigator: Antonella Poloni, MD         
U.O. Clinica Medicina Interna, IRCCS San Martino IST Recruiting
Genova, GE, Italy, 16132
Contact: Enrico Balleari, MD    +39 010 5555784    balleari@unige.it   
Principal Investigator: Enrico Balleari, MD         
Struttura Cattedra di Ematologia e CTMO, AOU di Parma Recruiting
Parma, PR, Italy, 43100
Contact: Monica Crugnola, MD    +39 0521-702494    mo@vodafone.it   
Contact    +39 0521-70      
Principal Investigator: Monica Crugnola, MD         
Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata Recruiting
Rionero in Vulture, PZ, Italy, 85028
Principal Investigator: Pellegrino Musto, MD         
S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano Recruiting
Torino, TO, Italy, 10128
Principal Investigator: Corrado Tarella, Prof.         
Ospedale Cardinal Massaia Recruiting
Asti, Italy
Principal Investigator: Giorgio Ciravegna, MD         
Ematologia AOU Policlinico di Bari Recruiting
Bari, Italy, 70124
Principal Investigator: Giorgina Specchia, Professor         
Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola Recruiting
Bologna, Italy, 40100
Principal Investigator: Carlo Finelli, Professor         
Ematologia- Ospedale Businco Recruiting
Cagliari, Italy, 09121
Principal Investigator: Emanuele Angelucci, MD         
Ospedale Maggiore Recruiting
Chieri, Italy
Principal Investigator: Gianni Cametti, MD         
Cattedra di Ematologia Policlino Careggi Recruiting
Firenze, Italy, 50134
Principal Investigator: Valeria Santini, Professor         
Dipartimento Emato-Oncologia AOU San Martino Genova Recruiting
Genova, Italy, 16132
Principal Investigator: Riccardo Ghio, MD         
Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
Principal Investigator: Giuseppe Saglio, Professor         
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Principal Investigator: Giampiero Semenzato, MD         
Azienda Ospedaliera Perugia Recruiting
Perugia, Italy
Principal Investigator: Anna Maria Liberati, MD         
AOU San Salvatore Recruiting
Pesaro, Italy, 61122
Principal Investigator: Giuseppe Visani, MD         
Ospedale San Giovanbni Battista-Molinette Recruiting
Torino, Italy
Principal Investigator: Umberto Vitolo, MD         
Divisione di Ematologia-Ospedale Cardinale Panico Recruiting
Tricase, Italy, 73039
Principal Investigator: Vincenzo Pavone, MD         
Sponsors and Collaborators
Fondazione Italiana Sindromi Mielodisplastiche Onlus

Responsible Party: Fondazione Italiana Sindromi Mielodisplastiche Onlus
ClinicalTrials.gov Identifier: NCT02808858     History of Changes
Other Study ID Numbers: Rete italiana registri MDS
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Keywords provided by Fondazione Italiana Sindromi Mielodisplastiche Onlus:
MDS
Myelodisplastic Syndrome

Additional relevant MeSH terms:
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases