Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES

• Conditions: Myelodysplastic Syndrome

• Registration Number: NCT01291745
• Lead Sponsor: Fondazione Amelia Scorza Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2011-02
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Last Update Submitted: 2011-02-07
• Study First Posted: 2011-02-08
• Last Update Posted: 2011-02-08
• Primary Completion: 2013-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (14)

U. O. C. Ematologia - Azienda Ospedaliera Sant'Andrea; 🇮🇹 Rome, Roma, Italy

U.O. Medicina Interna Universitaria 2 ed Ematologia Ospedale Civile San Salvatore; 🇮🇹 Coppito, L'Aquila, Italy

U.O. Ematologia - A.O. Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Dipartimento di Oncologia, Oncoematologia e Unità Trapianto di Midollo Osseo, 'La Maddalena'; 🇮🇹 Palermo, Italy

U.O.C. di Ematologia - Policlinico Agostino Gemelli-; 🇮🇹 Roma, Italy

Divisione di Ematologia Presidio Ospedaliero "A. Perrino"; 🇮🇹 Brindisi, Italy

Unità di Ematologia, Ospedale Madonna delle Grazie, ASM; 🇮🇹 Matera, Italy

Unità di Ematologia e Trapianto di Midollo Osseo, IRCCS-CROB, Centro di Riferimento Oncologico della Basilicata; 🇮🇹 Rionero in Vulture, Potenza, Italy

Divisione Clinicizzata di Ematologia con Trapianto di Midollo Osseo. Ospedale Ferrarotto. Azienda Policlinico; 🇮🇹 Catania, Italy

Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza; 🇮🇹 Cosenza, Italy

U.O. di Ematologia Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, Italy

S.O.C. Ematologia Azienda Ospedaliera di Catanzaro"Pugliese-Ciaccio"; 🇮🇹 Catanzaro, Italy

Divisione Ematologia - Azienda Ospedaliera "Bianchi-Melacrino-Morelli"; 🇮🇹 Reggio Calabria, Italy

Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza; 🇮🇹 Roma, Italy