Acute Myeloid Leukemia Clinical Trial
— SEIFEM 2010Official title:
SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia
NCT number | NCT01315925 |
Other study ID # | 751/2009 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | March 15, 2011 |
Last updated | March 15, 2011 |
Start date | January 2010 |
Verified date | March 2011 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - all newly diagnosed AML who accept to take part to the registry and sign an informed consent Exclusion Criteria: - relapsing/refractory AML - patients who do not sign informed consent |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | University of Ancona | Ancona | AN |
Italy | University of Bary | Bari | BA |
Italy | University of Bologna | Bologna | BO |
Italy | Hospital of Brescia | Brescia | |
Italy | University of Cagliari | Cagliari | |
Italy | Catholic University | Campobasso | |
Italy | Cuneo Hospital | Cuneo | |
Italy | Istotuto Meyer | Firenze | |
Italy | University of Firenze | Firenze | FI |
Italy | Gaslini Hospital | Genova | |
Italy | La Spezia Hospital | La Spezia | |
Italy | Lecce Hospital | Lecce | |
Italy | Lecce Pediatric Hospital | Lecce | |
Italy | Niguarda Hospital | Milano | MI |
Italy | University of Modena e Reggio | Modena | |
Italy | Monza Hospital | Monza | |
Italy | San Gerardo Hospital | Monza | |
Italy | "Federico II" University | Napoli | |
Italy | Cardarelli Hospital | Napoli | |
Italy | Pausilion Hospital | Napoli | |
Italy | University of Palermo | Palermo | |
Italy | University of Parma | Parma | |
Italy | S.Matteo Hospital, Department of Hematology | Pavia | |
Italy | S.Matteo Hospital, Department of Medicine | Pavia | |
Italy | University of Perugia | Perugia | |
Italy | University of Perugia, Pediatric Hematology | Perugia | |
Italy | Pescara Hospital | Pescara | |
Italy | Reggio Calabria Hospital | Reggio Calabria | |
Italy | Reggio Emilia Hospital | Reggio Emilia | |
Italy | Catholic University | Rome | RM |
Italy | IFO | Rome | RM |
Italy | S.Camillo Hospital | Rome | RM |
Italy | S.Giovanni Hospital | Rome | RM |
Italy | University of Tor Vergata | Rome | RM |
Italy | "Padre Pio" Hospital | San Giovanni Rotondo | |
Italy | Le Molinette Hospital | Torino | TO |
Italy | Regina Margherita Hospital | Torino | |
Italy | S.Anna Hospital | Torino | |
Italy | Tricase Hospital | Tricase | LE |
Italy | University of Udine | Udine | |
Italy | University of Verona | Verona | |
Italy | Verona Hospital | Verona |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
Caira M, Mancinelli M, Leone G, Pagano L. Invasive aspergillosis in acute leukemias: old and new risk factors and epidemiological trends. Med Mycol. 2011 Apr;49 Suppl 1:S13-6. doi: 10.3109/13693786.2010.509138. Epub 2010 Aug 26. — View Citation
Mühlemann K, Wenger C, Zenhäusern R, Täuber MG. Risk factors for invasive aspergillosis in neutropenic patients with hematologic malignancies. Leukemia. 2005 Apr;19(4):545-50. — View Citation
Pagano L, Caira M, Candoni A, Offidani M, Martino B, Specchia G, Pastore D, Stanzani M, Cattaneo C, Fanci R, Caramatti C, Rossini F, Luppi M, Potenza L, Ferrara F, Mitra ME, Fadda RM, Invernizzi R, Aloisi T, Picardi M, Bonini A, Vacca A, Chierichini A, Melillo L, de Waure C, Fianchi L, Riva M, Leone G, Aversa F, Nosari A. Invasive aspergillosis in patients with acute myeloid leukemia: a SEIFEM-2008 registry study. Haematologica. 2010 Apr;95(4):644-50. doi: 10.3324/haematol.2009.012054. Epub 2009 Oct 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Invasive fungal infections | To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others). | 30th day after the end of first line chemotherapy | No |
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