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Collection of Biological Data...

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

Last Updated: 2011-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Myelodysplastic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Unità Operativa di Ematologia- Azienda Ospedaliera di Cosenza

Principal Investigators

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Fortunato Morabito, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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