Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 14
- Primary Endpoint
- Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening
Time Frame: 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 Outcomes
- Validation of the prognostic potential of TET2 mutations(2 years)