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

This study is currently recruiting participants.
Verified February 2011 by Fondazione Amelia Scorza Onlus
Sponsor:
Information provided by:
Fondazione Amelia Scorza Onlus
ClinicalTrials.gov Identifier:
NCT01291745
First received: February 7, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted

February 7, 2011
February 7, 2011
September 2010
September 2013   (final data collection date for primary outcome measure)
Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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 )
Same as current
No Changes Posted
Validation of the prognostic potential of TET2 mutations [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Same as current
Not Provided
Not Provided
 
Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES
Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

bone marrow and buccal cell samples
Non-Probability Sample

Patients diagnosed with MDS detected by current diagnostic techniques (i.e., peripheral blood cytopenia, bone marrow morphology, cytogenetics andFISH analysis).
Myelodysplastic Syndrome
Not Provided
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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2015
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Fortunato Morabito, MD +390984681329 omdsprotocol@fondazioneameliascorza.it
Contact: Anna G Recchia, PhD +390984681539 omdsprotocol@fondazioneameliascorza.it
Italy
 
NCT01291745
O-MDS-PROTOCOL
No
Fortunato Morabito, MD, Unità Operativa di Ematologia- Azienda Ospedaliera di Cosenza
Fondazione Amelia Scorza Onlus
Not Provided
Principal Investigator: Fortunato Morabito, MD Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza - Italy
Fondazione Amelia Scorza Onlus
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP