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

Fondazione Amelia Scorza Onlus

Status: Unknown

Conditions: Myelodysplastic Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT01291745

O-MDS-PROTOCOL

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patients with MYELODYSPLASTIC SYNDROMES

Description:

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