Clinical trial NCT01291745: Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES
Official title: Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndrome
Lead sponsor: Fondazione Amelia Scorza Onlus
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with MDS detected by current diagnostic techniques (i.e., peripheral blood cytopenia, bone marrow morphology, cytogenetics andFISH analysis).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening
timeFrame: 2 years
Secondary outcomes:
measure: Validation of the prognostic potential of TET2 mutations
timeFrame: 2 years
Other outcomes:
Locations:
city: Coppito
country: Italy
facility: U.O. Medicina Interna Universitaria 2 ed Ematologia Ospedale Civile San Salvatore
state: L'Aquila
city: Rionero in Vulture
country: Italy
facility: Unità di Ematologia e Trapianto di Midollo Osseo, IRCCS-CROB, Centro di Riferimento Oncologico della Basilicata
state: Potenza
city: Rome
country: Italy
facility: U. O. C. Ematologia - Azienda Ospedaliera Sant'Andrea
state: Roma
city: Brescia
country: Italy
facility: U.O. Ematologia - A.O. Spedali Civili di Brescia
city: Brindisi
country: Italy
facility: Divisione di Ematologia Presidio Ospedaliero "A. Perrino"
city: Catania
country: Italy
facility: Divisione Clinicizzata di Ematologia con Trapianto di Midollo Osseo. Ospedale Ferrarotto. Azienda Policlinico
city: Catanzaro
country: Italy
facility: S.O.C. Ematologia Azienda Ospedaliera di Catanzaro"Pugliese-Ciaccio"
city: Cosenza
country: Italy
facility: Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza
city: Matera
country: Italy
facility: Unità di Ematologia, Ospedale Madonna delle Grazie, ASM
city: Palermo
country: Italy
facility: Dipartimento di Oncologia, Oncoematologia e Unità Trapianto di Midollo Osseo, 'La Maddalena'
city: Pisa
country: Italy
facility: U.O. di Ematologia Azienda Ospedaliera Universitaria Pisana
city: Reggio Calabria
country: Italy
facility: Divisione Ematologia - Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
city: Roma
country: Italy
facility: Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza
city: Roma
country: Italy
facility: U.O.C. di Ematologia - Policlinico Agostino Gemelli-
Study officials:
affiliation: Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza - Italy
name: Fortunato Morabito, MD
role: PRINCIPAL_INVESTIGATOR
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