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Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)

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ClinicalTrials.gov Identifier: NCT01315925
Recruitment Status : Unknown
Verified March 2011 by Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : March 16, 2011
Last Update Posted : March 16, 2011
Information provided by:
Catholic University of the Sacred Heart

Brief Summary:
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).

Condition or disease
Acute Myeloid Leukemia Aspergillosis Candidiasis Mycoses

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia
Study Start Date : January 2010

Newly disgnosed AML
Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a non-interventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.

Primary Outcome Measures :
  1. Incidence of Invasive fungal infections [ Time Frame: 30th day after the end of first line chemotherapy ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315925

University of Ancona Recruiting
Ancona, AN, Italy
Contact: Massimo Offidani, MD       m.offidani@ao-umbertoprimo.marche.it   
Principal Investigator: Massimo Offidani, MD         
University of Bary Recruiting
Bari, BA, Italy
Contact: Mario Delia, MD       mario.delia74@gmail.com   
Principal Investigator: Giorgina Specchia         
Sub-Investigator: Mario Delia         
University of Bologna Recruiting
Bologna, BO, Italy
Contact: Nicola Vianelli       nicola.vianelli@unibo.it   
Principal Investigator: Nicola Vianelli         
University of Firenze Recruiting
Firenze, FI, Italy
Contact: Rosa Fanci, MD       r.fanci@dac.unifi.it   
Principal Investigator: Rosa Fanci         
Tricase Hospital Recruiting
Tricase, LE, Italy
Contact: Vincenzo Pavone       salentoematologia@piafondazionepanico.it   
Niguarda Hospital Recruiting
Milano, MI, Italy
Contact: Annamaria Nosari, MD       annamaria.nosari@ospedaleniguarda.it   
Principal Investigator: Annamaria Nosari, MD         
Catholic University Recruiting
Rome, RM, Italy, 00168
Contact: Livio Pagano, MD    +390630154180    lpagano@rm.unicatt.it   
Principal Investigator: Livio Pagano, MD         
Sub-Investigator: Morena Caira, MD         
Sub-Investigator: Mario Mancinelli, MD         
IFO Active, not recruiting
Rome, RM, Italy
S.Camillo Hospital Recruiting
Rome, RM, Italy
Contact: Maria Grazia Garzia       mariagraziagarzia@hotmail.com   
S.Giovanni Hospital Recruiting
Rome, RM, Italy
Contact: Anna Chierichini       annachierichini@hotmail.com   
University of Tor Vergata Recruiting
Rome, RM, Italy
Contact: Adriano Venditti       adriano.venditti@uniroma2.it   
Le Molinette Hospital Recruiting
Torino, TO, Italy
Contact: Alessandro Busca       abusca@molinette.piemonte.it   
Hospital of Brescia Recruiting
Brescia, Italy
Contact: Chiara Cattaneo, MD       chiara.cattaneo@libero.it   
Sub-Investigator: Chiara Cattaneo         
Principal Investigator: Giuseppe Rossi         
University of Cagliari Recruiting
Cagliari, Italy
Contact: Adriana Vacca       vaccaadriana@gmail.com   
Catholic University Recruiting
Campobasso, Italy
Contact: Cristina Gasbarrino       gasbacri@virgilio.it   
Principal Investigator: Sergio Storti         
Cuneo Hospital Active, not recruiting
Cuneo, Italy
Istotuto Meyer Recruiting
Firenze, Italy
Contact: Desiree Caselli       d.caselli@meyer.it   
Gaslini Hospital Recruiting
Genova, Italy
Contact: Elio Castagnola       eliocastagnola@ospedale-gaslini.ge.it   
La Spezia Hospital Recruiting
La Spezia, Italy
Contact: Annunziata Manna       annunziata.manna@asl5.liguria.it   
Lecce Hospital Recruiting
Lecce, Italy
Contact: De Paolis       depaolis.ematolecce@libero.it   
Lecce Pediatric Hospital Active, not recruiting
Lecce, Italy
University of Modena e Reggio Recruiting
Modena, Italy
Contact: Mario Luppi       mluppi@unimore.it   
Principal Investigator: Mario Luppi         
Monza Hospital Recruiting
Monza, Italy
Contact: Luisa Verga       luisa.verga@libero.it   
San Gerardo Hospital Active, not recruiting
Monza, Italy
"Federico II" University Recruiting
Napoli, Italy
Contact: Marco Picardi, MD       picardi@ceinge.unina.it   
Cardarelli Hospital Active, not recruiting
Napoli, Italy
Pausilion Hospital Active, not recruiting
Napoli, Italy
University of Palermo Recruiting
Palermo, Italy
Contact: Maria Enza Mitra       memitra@yahoo.com   
Principal Investigator: Maria Enza Mitra         
University of Parma Recruiting
Parma, Italy
Contact: Cecilia Caramatti       cecilia.caramatti@unipr.it   
S.Matteo Hospital, Department of Hematology Recruiting
Pavia, Italy
Contact: Carlo Castagnola       castagnola@smatteo.pv.it   
Principal Investigator: Carlo Castagnola         
S.Matteo Hospital, Department of Medicine Recruiting
Pavia, Italy
Contact: Rosangela Invernizzi       r.invernizzi@smatteo.pv.it   
University of Perugia, Pediatric Hematology Recruiting
Perugia, Italy
Contact: Franco Aversa       aversa@unipg.it   
University of Perugia Recruiting
Perugia, Italy
Contact: Franco Aversa       aversa@unipg.it   
Principal Investigator: Franco Aversa         
Pescara Hospital Recruiting
Pescara, Italy
Contact: Prassede Salutari       prassede.salutari@email.it   
Reggio Calabria Hospital Recruiting
Reggio Calabria, Italy
Contact: Bruno Martino       brunmartin@libero.it   
Reggio Emilia Hospital Recruiting
Reggio Emilia, Italy
Contact: Alessandro Bonini       Alessandro.Bonini@asmn.re.it   
"Padre Pio" Hospital Recruiting
San Giovanni Rotondo, Italy
Contact: Lorella Melillo       l.melillo@operapadrepio.it   
Regina Margherita Hospital Active, not recruiting
Torino, Italy
S.Anna Hospital Recruiting
Torino, Italy
Contact: Mareva Giacchino       mareva.giacchino@unito.it   
University of Udine Recruiting
Udine, Italy
Contact: Anna Candoni       candoni.anna@aoud.sanita.fvg.it   
University of Verona Recruiting
Verona, Italy
Contact: Gianpaolo Nadali       gianpaolo.nadali@univr.it   
Verona Hospital Recruiting
Verona, Italy
Contact: Simone Cesaro       simone.cesaro@azosp.vr.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Caira M, Candoni A, Verga L, Busca A, Delia M, Nosari A, Caramatti C, Castagnola C, Cattaneo C, Fanci R, Chierichini A, Melillo L, Mitra ME, Picardi M, Potenza L, Salutari P, Vianelli N, Facchini L, Cesarini M, De Paolis MR, Di Blasi R, Farina F, Venditti A, Ferrari A, Garzia M, Gasbarrino C, Invernizzi R, Lessi F, Manna A, Martino B, Nadali G, Offidani M, Paris L, Pavone V, Rossi G, Spadea A, Specchia G, Trecarichi EM, Vacca A, Cesaro S, Perriello V, Aversa F, Tumbarello M, Pagano L; SEIFEM Group (Sorveglianza Epidemiologica Infezioni Fungine in Emopatie Maligne). Pre-chemotherapy risk factors for invasive fungal diseases: prospective analysis of 1,192 patients with newly diagnosed acute myeloid leukemia (SEIFEM 2010-a multicenter study). Haematologica. 2015 Feb;100(2):284-92. doi: 10.3324/haematol.2014.113399.

Responsible Party: Livio Pagano, MD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01315925     History of Changes
Other Study ID Numbers: 751/2009
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Keywords provided by Catholic University of the Sacred Heart:
Acute myeloid leukemia
invasive fungal infection

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Invasive Fungal Infections
Neoplasms by Histologic Type
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases