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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01291745

Acronym

O-MDS-Protocol

Enrollment

200

Registered

2011-02-08

Start date

2010-09-30

Completion date

2015-09-30

Last updated

2011-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening	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

Measure	Time frame	Description
Validation of the prognostic potential of TET2 mutations	2 years	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

Countries

Italy

Contacts

Primary ContactFortunato Morabito, MD

omdsprotocol@fondazioneameliascorza.it+390984681329

Backup ContactAnna G Recchia, PhD

omdsprotocol@fondazioneameliascorza.it+390984681539

Outcome results