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

NCT01291745 | Unknown

• 1 other identifier: O-MDS-PROTOCOL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 14

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.

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Validation of the prognostic potential of TET2 mutations

  2 years

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Patients who do not require treatment on "watch and wait" strategy
• Insufficient amount of biological samples for molecular studies

Sponsors & Collaborators

• Fondazione Amelia Scorza Onlus: lead

Study Sites (14)

U.O. Ematologia - A.O. Spedali Civili di Brescia

Brescia, Brescia, Italy

NOT YET RECRUITING

Divisione di Ematologia Presidio Ospedaliero "A. Perrino"

Brindisi, Brindisi, Italy

NOT YET RECRUITING

Divisione Clinicizzata di Ematologia con Trapianto di Midollo Osseo. Ospedale Ferrarotto. Azienda Policlinico

Catania, Catania, Italy

NOT YET RECRUITING

S.O.C. Ematologia Azienda Ospedaliera di Catanzaro"Pugliese-Ciaccio"

Catanzaro, Catanzaro, Italy

NOT YET RECRUITING

Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza

Cosenza, Cosenza, 87100, Italy

RECRUITING

U.O. Medicina Interna Universitaria 2 ed Ematologia Ospedale Civile San Salvatore

Coppito, L'Aquila, 67010, Italy

NOT YET RECRUITING

Unità di Ematologia, Ospedale Madonna delle Grazie, ASM

Matera, Matera, Italy

NOT YET RECRUITING

Dipartimento di Oncologia, Oncoematologia e Unità Trapianto di Midollo Osseo, 'La Maddalena'

Palermo, Palermo, Italy

NOT YET RECRUITING

U.O. di Ematologia Azienda Ospedaliera Universitaria Pisana

Pisa, Pisa, Italy

NOT YET RECRUITING

Unità di Ematologia e Trapianto di Midollo Osseo, IRCCS-CROB, Centro di Riferimento Oncologico della Basilicata

Rionero in Vulture, Potenza, Italy

NOT YET RECRUITING

Divisione Ematologia - Azienda Ospedaliera "Bianchi-Melacrino-Morelli"

Reggio Calabria, Reggio Calabria, Italy

NOT YET RECRUITING

Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza

Roma, Roma, 00161, Italy

NOT YET RECRUITING

U.O.C. di Ematologia - Policlinico Agostino Gemelli-

Roma, Roma, Italy

NOT YET RECRUITING

U. O. C. Ematologia - Azienda Ospedaliera Sant'Andrea

Rome, Roma, 00189, Italy

NOT YET RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

bone marrow and buccal cell samples

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Fortunato Morabito, MD

  Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza - Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fortunato Morabito, MD

CONTACT

+390984681329; omdsprotocol@fondazioneameliascorza.it

Anna G Recchia, PhD

CONTACT

+390984681539; omdsprotocol@fondazioneameliascorza.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 8, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2015
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

IT (14)