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Myelodysplastic SyndromeO-MDS-ProtocolNCT01291745

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

An observational study of Myelodysplastic Syndrome, run by Fondazione Amelia Scorza Onlus at 14 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndrome
How many people
200 participants
Where
14 sitesItaly
Study dates
Sep 2010to Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with MDS detected by current diagnostic techniques (i.e., peripheral blood cytopenia, bone marrow morphology, cytogenetics andFISH analysis).

Who may be able to join

  • 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

Who cannot join

  • Age <18 years
  • Patients who do not require treatment on "watch and wait" strategy
  • Insufficient amount of biological samples for molecular studies

Trial locations and contacts

14 sites in 1 country.

Fortunato Morabito, MD contact

+390984681329

omdsprotocol@fondazioneameliascorza.it

Anna G Recchia, PhD contact

+390984681539

omdsprotocol@fondazioneameliascorza.it

14 sites in 1 country

Italy14 sites, 14 recruiting

  • U.O. Ematologia - A.O. Spedali Civili di Brescia

    Brescia, Brescia

    Giuseppe Rossi, MD, +390303996573, ematologia@spedalicivili.brescia.it

    Giuseppe Rossi, MD

    Not yet recruiting

  • Divisione di Ematologia Presidio Ospedaliero "A. Perrino"

    Brindisi, Brindisi

    Giovanni Quarta, MD, +390831537507, quarta.gianni@gmail.com

    Giovanni Quarta, MD

    Not yet recruiting

  • Divisione Clinicizzata di Ematologia con Trapianto di Midollo Osseo. Ospedale Ferrarotto. Azienda Policlinico

    Catania, Catania

    Giuseppe Palumbo, MD, ga.palumbo@gmail.com

    Giuseppe Palumbo, MD

    Not yet recruiting

  • S.O.C. Ematologia Azienda Ospedaliera di Catanzaro"Pugliese-Ciaccio"

    Catanzaro, Catanzaro

    Domenico Magro, MD, +390961883120, magro.dom@virgilio.it

    Domenico Magro, MD

    Not yet recruiting

  • U.O. Medicina Interna Universitaria 2 ed Ematologia Ospedale Civile San Salvatore

    Coppito, L'Aquila, 67010

    Alessandro Lucchesi, MD, +390862368589, ale.lucchesi@gmail.com

    Alessandro Lucchesi, MD

    Not yet recruiting

  • Unità Operativa Complessa di Ematologia- Azienda Ospedaliera di Cosenza

    Cosenza, Cosenza, 87100

    Fortunato Morabito, MD, +390984681329, omdsprotocol@fondazioneameliascorza.it

    Fortunato Morabito, MD

    Recruiting

  • Unità di Ematologia, Ospedale Madonna delle Grazie, ASM

    Matera, Matera

    Alberto Fragasso, MD, alberto.fragasso@libero.it

    Alberto Fragasso, MD

    Not yet recruiting

  • Dipartimento di Oncologia, Oncoematologia e Unità Trapianto di Midollo Osseo, 'La Maddalena'

    Palermo, Palermo

    Maurizio Musso, MD, +390916806814, mamusso@libero.it

    Maurizio Musso, MD

    Not yet recruiting

  • U.O. di Ematologia Azienda Ospedaliera Universitaria Pisana

    Pisa, Pisa

    Mario Petrini, MD

    Sara Galimberti, MD, s.galimberti@med.unipi.it

    Not yet recruiting

  • Divisione Ematologia - Azienda Ospedaliera "Bianchi-Melacrino-Morelli"

    Reggio Calabria, Reggio Calabria

    Esther Oliva, MD, estheroliva@hotmail.com

    Esther Oliva, MD

    Not yet recruiting

  • Unità di Ematologia e Trapianto di Midollo Osseo, IRCCS-CROB, Centro di Riferimento Oncologico della Basilicata

    Rionero in Vulture, Potenza

    Pellegrino Musto, MD, +390972726225, p.musto@crob.it

    Pellegrino Musto, MD

    Not yet recruiting

  • Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza

    Roma, Roma, 00161

    Giuliana Alimena, MD, alimena@bce.uniroma1.it

    Giuliana Alimena, MD

    Not yet recruiting

  • U.O.C. di Ematologia - Policlinico Agostino Gemelli-

    Roma, Roma

    Maria T Voso, MD, 0630154278 ext. 0039, mtvoso@rm.unicatt.it

    Maria T Voso, MD

    Not yet recruiting

  • U. O. C. Ematologia - Azienda Ospedaliera Sant'Andrea

    Rome, Roma, 00189

    Maria A Aloe Spiriti, MD, +390633775052, aloespiritisapienza@gmail.com

    Maria A Aloe Spiriti, MD

    Not yet recruiting

Other trials in Italy

About this study

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.

Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01291745
Study groupRoleWhat they receive
Patients with MYELODYSPLASTIC SYNDROMESPatients diagnosed with MDS according to FAB, WHO and IPSS classifications. Patients who necessitate to start a treatment (i.e. EPO, Lenalidomide, Azacytidine).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening

    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 )

    Measured: 2 years

Secondary outcomes (1)

  1. Validation of the prognostic potential of TET2 mutations

    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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionSep 2013 (estimated)
  4. Study completionSep 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01291745
Sponsor's protocol ID
O-MDS-PROTOCOL
Acronym
O-MDS-Protocol
Status last verified
Feb 2011
First submitted
7 Feb 2011
Last updated
8 Feb 2011
Results posted
No
Data monitoring committee
No

Publications

  • Abdel-Wahab O, Mullally A, Hedvat C, Garcia-Manero G, Patel J, Wadleigh M, Malinge S, Yao J, Kilpivaara O, Bhat R, Huberman K, Thomas S, Dolgalev I, Heguy A, Paietta E, Le Beau MM, Beran M, Tallman MS, Ebert BL, Kantarjian HM, Stone RM, Gilliland DG, Crispino JD, Levine RL. Genetic characterization of TET1, TET2, and TET3 alterations in myeloid malignancies. Blood. 2009 Jul 2;114(1):144-7. doi: 10.1182/blood-2009-03-210039. Epub 2009 May 6.

    PubMed 19420352

  • 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 Jul;89(7):643-52. doi: 10.1007/s00277-010-0920-6. Epub 2010 Mar 2.

    PubMed 20195608

  • Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton DA, Gralnick HR, Sultan C. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982 Jun;51(2):189-99.

    PubMed 6952920

  • Cazzola M, Malcovati L. Myelodysplastic syndromes--coping with ineffective hematopoiesis. N Engl J Med. 2005 Feb 10;352(6):536-8. doi: 10.1056/NEJMp048266. No abstract available.

    PubMed 15703418

  • Couronne L, Lippert E, Andrieux J, Kosmider O, Radford-Weiss I, Penther D, Dastugue N, Mugneret F, Lafage M, Gachard N, Nadal N, Bernard OA, Nguyen-Khac F. Analyses of TET2 mutations in post-myeloproliferative neoplasm acute myeloid leukemias. Leukemia. 2010 Jan;24(1):201-3. doi: 10.1038/leu.2009.169. Epub 2009 Aug 27. No abstract available.

    PubMed 19710701

  • Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.

    PubMed 9058730

  • Harris NL, Jaffe ES, Diebold J, Flandrin G, Muller-Hermelink HK, Vardiman J, Lister TA, Bloomfield CD. The World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues. Report of the Clinical Advisory Committee meeting, Airlie House, Virginia, November, 1997. Ann Oncol. 1999 Dec;10(12):1419-32. doi: 10.1023/a:1008375931236.

    PubMed 10643532

  • Kosmider O, Gelsi-Boyer V, Cheok M, Grabar S, Della-Valle V, Picard F, Viguie F, Quesnel B, Beyne-Rauzy O, Solary E, Vey N, Hunault-Berger M, Fenaux P, Mansat-De Mas V, Delabesse E, Guardiola P, Lacombe C, Vainchenker W, Preudhomme C, Dreyfus F, Bernard OA, Birnbaum D, Fontenay M; Groupe Francophone des Myelodysplasies. TET2 mutation is an independent favorable prognostic factor in myelodysplastic syndromes (MDSs). Blood. 2009 Oct 8;114(15):3285-91. doi: 10.1182/blood-2009-04-215814. Epub 2009 Aug 7.

    PubMed 19666869

  • Langemeijer SM, Kuiper RP, Berends M, Knops R, Aslanyan MG, Massop M, Stevens-Linders E, van Hoogen P, van Kessel AG, Raymakers RA, Kamping EJ, Verhoef GE, Verburgh E, Hagemeijer A, Vandenberghe P, de Witte T, van der Reijden BA, Jansen JH. Acquired mutations in TET2 are common in myelodysplastic syndromes. Nat Genet. 2009 Jul;41(7):838-42. doi: 10.1038/ng.391. Epub 2009 May 31.

    PubMed 19483684

  • Lorsbach RB, Moore J, Mathew S, Raimondi SC, Mukatira ST, Downing JR. TET1, a member of a novel protein family, is fused to MLL in acute myeloid leukemia containing the t(10;11)(q22;q23). Leukemia. 2003 Mar;17(3):637-41. doi: 10.1038/sj.leu.2402834. No abstract available.

    PubMed 12646957

  • Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival in the United States. Cancer. 2007 Apr 15;109(8):1536-42. doi: 10.1002/cncr.22570.

    PubMed 17345612

  • Malcovati L, Nimer SD. Myelodysplastic syndromes: diagnosis and staging. Cancer Control. 2008 Oct;15 Suppl:4-13. doi: 10.1177/107327480801504s02.

    PubMed 18813205

  • Nie HH, H.H., Jenkins JG, Steinmrenner K, Bent DH., SPSS (Statistical Package for the Social Science). 1979, New York, NY: McGraw-Hill.

  • Ono R, Taki T, Taketani T, Taniwaki M, Kobayashi H, Hayashi Y. LCX, leukemia-associated protein with a CXXC domain, is fused to MLL in acute myeloid leukemia with trilineage dysplasia having t(10;11)(q22;q23). Cancer Res. 2002 Jul 15;62(14):4075-80.

    PubMed 12124344

  • Rollison DE, Howlader N, Smith MT, Strom SS, Merritt WD, Ries LA, Edwards BK, List AF. Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008 Jul 1;112(1):45-52. doi: 10.1182/blood-2008-01-134858. Epub 2008 Apr 28.

    PubMed 18443215

Questions about this trial

What is this clinical trial studying?

An observational study of Myelodysplastic Syndrome, run by Fondazione Amelia Scorza Onlus at 14 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fortunato Morabito, MD (+390984681329, omdsprotocol@fondazioneameliascorza.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01291745, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2011.

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