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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Fondazione Amelia Scorza Onlus.
Recruitment status was:  Recruiting
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
  Purpose
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.

Condition
Myelodysplastic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES

Resource links provided by NLM:


Further study details as provided by Fondazione Amelia Scorza Onlus:

Primary Outcome Measures:
  • 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 )


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
bone marrow and buccal cell samples

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with MDS detected by current diagnostic techniques (i.e., peripheral blood cytopenia, bone marrow morphology, cytogenetics andFISH analysis).
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291745

Locations
Italy
U.O. Medicina Interna Universitaria 2 ed Ematologia Ospedale Civile San Salvatore
Coppito, L'Aquila, Italy, 67010
Unità di Ematologia e Trapianto di Midollo Osseo, IRCCS-CROB, Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, Potenza, Italy
U. O. C. Ematologia - Azienda Ospedaliera Sant'Andrea
Rome, Roma, Italy, 00189
U.O. Ematologia - A.O. Spedali Civili di Brescia
Brescia, Italy
Divisione di Ematologia Presidio Ospedaliero "A. Perrino"
Brindisi, Italy
Divisione Clinicizzata di Ematologia con Trapianto di Midollo Osseo. Ospedale Ferrarotto. Azienda Policlinico
Catania, Italy
S.O.C. Ematologia Azienda Ospedaliera di Catanzaro"Pugliese-Ciaccio"
Catanzaro, Italy
Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza
Cosenza, Italy, 87100
Unità di Ematologia, Ospedale Madonna delle Grazie, ASM
Matera, Italy
Dipartimento di Oncologia, Oncoematologia e Unità Trapianto di Midollo Osseo, 'La Maddalena'
Palermo, Italy
U.O. di Ematologia Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Divisione Ematologia - Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza
Roma, Italy, 00161
U.O.C. di Ematologia - Policlinico Agostino Gemelli-
Roma, Italy
Sponsors and Collaborators
Fondazione Amelia Scorza Onlus
Investigators
Principal Investigator: Fortunato Morabito, MD Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza - Italy
  More Information

Publications:
Nie HH, H.H., Jenkins JG, Steinmrenner K, Bent DH., SPSS (Statistical Package for the Social Science). 1979, New York, NY: McGraw-Hill.
Swerdlow SH, Campo E, Harris NL, Jaffe ES, Pileri SA, Stein H et al, eds. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC: Lyon, 2008.

Responsible Party: Fortunato Morabito, MD, Unità Operativa di Ematologia- Azienda Ospedaliera di Cosenza
ClinicalTrials.gov Identifier: NCT01291745     History of Changes
Other Study ID Numbers: O-MDS-PROTOCOL 
Study First Received: February 7, 2011
Last Updated: February 7, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on December 09, 2016