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

Myelodysplastic Syndrome Clinical Trial

— O-MDS-Protocol  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01291745
• Other study ID #: O-MDS-PROTOCOL
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2011
• Last updated: February 7, 2011
• Start date: September 2010
• Est. completion date: September 2015

Study information

• Verified date: February 2011
• Source: Fondazione Amelia Scorza Onlus
• Contact: Fortunato Morabito, MD
• Phone: +390984681329
• Email: omdsprotocol[@]fondazioneameliascorza.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Amelia Scorza Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening	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 )	2 years	No
Secondary	Validation of the prognostic potential of TET2 mutations	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	2 years	No