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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
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

Contacts
Contact: Fortunato Morabito, MD +390984681329 omdsprotocol@fondazioneameliascorza.it
Contact: Anna G Recchia, PhD +390984681539 omdsprotocol@fondazioneameliascorza.it

Locations
Italy
U.O. Medicina Interna Universitaria 2 ed Ematologia Ospedale Civile San Salvatore Not yet recruiting
Coppito, L'Aquila, Italy, 67010
Contact: Alessandro Lucchesi, MD    +390862368589    ale.lucchesi@gmail.com   
Sub-Investigator: Alessandro Lucchesi, MD         
Unità di Ematologia e Trapianto di Midollo Osseo, IRCCS-CROB, Centro di Riferimento Oncologico della Basilicata Not yet recruiting
Rionero in Vulture, Potenza, Italy
Contact: Pellegrino Musto, MD    +390972726225    p.musto@crob.it   
Sub-Investigator: Pellegrino Musto, MD         
U. O. C. Ematologia - Azienda Ospedaliera Sant'Andrea Not yet recruiting
Rome, Roma, Italy, 00189
Contact: Maria A Aloe Spiriti, MD    +390633775052    aloespiritisapienza@gmail.com   
Sub-Investigator: Maria A Aloe Spiriti, MD         
U.O. Ematologia - A.O. Spedali Civili di Brescia Not yet recruiting
Brescia, Italy
Contact: Giuseppe Rossi, MD    +390303996573    ematologia@spedalicivili.brescia.it   
Sub-Investigator: Giuseppe Rossi, MD         
Divisione di Ematologia Presidio Ospedaliero "A. Perrino" Not yet recruiting
Brindisi, Italy
Contact: Giovanni Quarta, MD    +390831537507    quarta.gianni@gmail.com   
Sub-Investigator: Giovanni Quarta, MD         
Divisione Clinicizzata di Ematologia con Trapianto di Midollo Osseo. Ospedale Ferrarotto. Azienda Policlinico Not yet recruiting
Catania, Italy
Contact: Giuseppe Palumbo, MD       ga.palumbo@gmail.com   
Sub-Investigator: Giuseppe Palumbo, MD         
S.O.C. Ematologia Azienda Ospedaliera di Catanzaro"Pugliese-Ciaccio" Not yet recruiting
Catanzaro, Italy
Contact: Domenico Magro, MD    +390961883120    magro.dom@virgilio.it   
Sub-Investigator: Domenico Magro, MD         
Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza Recruiting
Cosenza, Italy, 87100
Contact: Fortunato Morabito, MD    +390984681329    omdsprotocol@fondazioneameliascorza.it   
Principal Investigator: Fortunato Morabito, MD         
Unità di Ematologia, Ospedale Madonna delle Grazie, ASM Not yet recruiting
Matera, Italy
Contact: Alberto Fragasso, MD       alberto.fragasso@libero.it   
Sub-Investigator: Alberto Fragasso, MD         
Dipartimento di Oncologia, Oncoematologia e Unità Trapianto di Midollo Osseo, 'La Maddalena' Not yet recruiting
Palermo, Italy
Contact: Maurizio Musso, MD    +390916806814    mamusso@libero.it   
Sub-Investigator: Maurizio Musso, MD         
U.O. di Ematologia Azienda Ospedaliera Universitaria Pisana Not yet recruiting
Pisa, Italy
Contact: Mario Petrini, MD         
Contact: Sara Galimberti, MD       s.galimberti@med.unipi.it   
Sub-Investigator: Sara Galimberti, MD         
Divisione Ematologia - Azienda Ospedaliera "Bianchi-Melacrino-Morelli" Not yet recruiting
Reggio Calabria, Italy
Contact: Esther Oliva, MD       estheroliva@hotmail.com   
Sub-Investigator: Esther Oliva, MD         
Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza Not yet recruiting
Roma, Italy, 00161
Contact: Giuliana Alimena, MD       alimena@bce.uniroma1.it   
Sub-Investigator: Giuliana Alimena, MD         
U.O.C. di Ematologia - Policlinico Agostino Gemelli- Not yet recruiting
Roma, Italy
Contact: Maria T Voso, MD    0630154278 ext 0039    mtvoso@rm.unicatt.it   
Sub-Investigator: Maria T Voso, MD         
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:
Bacher U, Haferlach C, Schnittger S, Kohlmann A, Kern W, Haferlach T. Mutations of the TET2 and CBL genes: novel molecular markers in myeloid malignancies. Ann Hematol. 2010 Mar 2. [Epub ahead of print] PubMed PMID: 20195608.

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:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on September 11, 2014