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O-MDS-Protocol: Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES

Sponsor
Fondazione Amelia Scorza Onlus (Other)
Overall Status
Unknown status
CT.gov ID
NCT01291745
Collaborator
(none)
200
Enrollment
14
Locations
60
Duration (Months)
14.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study is designed to determine the mutational status of markers (TET2 and PLCb2, cytogenetic aberrations) together with methylation status of the above genes using bone marrow and matched buccal cell samples from MDS patients who necessitate to start a treatment (i.e. EPO, Lenalidomide, Azacytidine). All patients included in the study will be followed for at least 2 years.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES
    Study Start Date :
    Sep 1, 2010
    Anticipated Primary Completion Date :
    Sep 1, 2013
    Anticipated Study Completion Date :
    Sep 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with MYELODYSPLASTIC SYNDROMES

    Patients diagnosed with MDS according to FAB, WHO and IPSS classifications. Patients who necessitate to start a treatment (i.e. EPO, Lenalidomide, Azacytidine).

    Outcome Measures

    Primary Outcome Measures

    1. Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening [2 years]

      Analyze the incidence of TET2 gene mutations in a series of MDS patients and describe the clinical status of patients carrying mutations Validation of the prognostic potential of TET2 mutations and MPLA screening on: Response rate to treatment with Epo, Lenalidomide and Azacitidine Progression Free Survival (PFS )

    Secondary Outcome Measures

    1. Validation of the prognostic potential of TET2 mutations [2 years]

      Validation of the prognostic potential of Tet2 mutations on: Overall Survival; Validation of MLPA analyisis in the identification of cytogenetic abnormalities in MDS patients as a complementary screening tool; Validation of the prognostic relevance of MLPA analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent

    • Patients diagnosed with MDS according to FAB, WHO and IPSS classifications

    • All clinically treatable MDS patients with EPO or Lenalidomide or 5-Azacytidine;

    • Hb < 10 g/dL

    • Age ≥ 18 years

    • Gender: Male or Female

    • Sufficient amount of biological samples for molecular studies

    Exclusion Criteria:

    • Age <18 years

    • Patients who do not require treatment on "watch and wait" strategy

    • Insufficient amount of biological samples for molecular studies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 U.O. Medicina Interna Universitaria 2 ed Ematologia Ospedale Civile San Salvatore Coppito L'Aquila Italy 67010
    2 Unità di Ematologia e Trapianto di Midollo Osseo, IRCCS-CROB, Centro di Riferimento Oncologico della Basilicata Rionero in Vulture Potenza Italy
    3 U. O. C. Ematologia - Azienda Ospedaliera Sant'Andrea Rome Roma Italy 00189
    4 U.O. Ematologia - A.O. Spedali Civili di Brescia Brescia Italy
    5 Divisione di Ematologia Presidio Ospedaliero "A. Perrino" Brindisi Italy
    6 Divisione Clinicizzata di Ematologia con Trapianto di Midollo Osseo. Ospedale Ferrarotto. Azienda Policlinico Catania Italy
    7 S.O.C. Ematologia Azienda Ospedaliera di Catanzaro"Pugliese-Ciaccio" Catanzaro Italy
    8 Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza Cosenza Italy 87100
    9 Unità di Ematologia, Ospedale Madonna delle Grazie, ASM Matera Italy
    10 Dipartimento di Oncologia, Oncoematologia e Unità Trapianto di Midollo Osseo, 'La Maddalena' Palermo Italy
    11 U.O. di Ematologia Azienda Ospedaliera Universitaria Pisana Pisa Italy
    12 Divisione Ematologia - Azienda Ospedaliera "Bianchi-Melacrino-Morelli" Reggio Calabria Italy
    13 Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza Roma Italy 00161
    14 U.O.C. di Ematologia - Policlinico Agostino Gemelli- Roma Italy

    Sponsors and Collaborators

    • Fondazione Amelia Scorza Onlus

    Investigators

    • Principal Investigator: Fortunato Morabito, MD, Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza - Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01291745
    Other Study ID Numbers:
    • O-MDS-PROTOCOL
    First Posted:
    Feb 8, 2011
    Last Update Posted:
    Feb 8, 2011
    Last Verified:
    Feb 1, 2011
    Additional relevant MeSH terms:
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome

    Study Results

    No Results Posted as of Feb 8, 2011