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

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 March 2011 by Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01315925
First received: March 15, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose
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
Acute Myeloid Leukemia
Aspergillosis
Candidiasis
Mycoses

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Incidence of Invasive fungal infections [ Time Frame: 30th day after the end of first line chemotherapy ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1000
Study Start Date: January 2010
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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.
Criteria

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
  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: NCT01315925

Locations
Italy
University of Ancona
Ancona, AN, Italy
University of Bary
Bari, BA, Italy
University of Bologna
Bologna, BO, Italy
University of Firenze
Firenze, FI, Italy
Tricase Hospital
Tricase, LE, Italy
Niguarda Hospital
Milano, MI, Italy
Catholic University
Rome, RM, Italy, 00168
IFO
Rome, RM, Italy
S.Camillo Hospital
Rome, RM, Italy
S.Giovanni Hospital
Rome, RM, Italy
University of Tor Vergata
Rome, RM, Italy
Le Molinette Hospital
Torino, TO, Italy
Hospital of Brescia
Brescia, Italy
University of Cagliari
Cagliari, Italy
Catholic University
Campobasso, Italy
Cuneo Hospital
Cuneo, Italy
Istotuto Meyer
Firenze, Italy
Gaslini Hospital
Genova, Italy
La Spezia Hospital
La Spezia, Italy
Lecce Hospital
Lecce, Italy
Lecce Pediatric Hospital
Lecce, 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, Pediatric Hematology
Perugia, Italy
University of Perugia
Perugia, Italy
Pescara Hospital
Pescara, Italy
Reggio Calabria Hospital
Reggio Calabria, Italy
Reggio Emilia Hospital
Reggio Emilia, Italy
"Padre Pio" Hospital
San Giovanni Rotondo, Italy
Regina Margherita Hospital
Torino, Italy
S.Anna Hospital
Torino, Italy
University of Udine
Udine, Italy
University of Verona
Verona, Italy
Verona Hospital
Verona, Italy
Sponsors and Collaborators
Catholic University of the Sacred Heart
  More Information

Publications:
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 
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Infection
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Mycoses
Aspergillosis
Candidiasis
Neoplasms by Histologic Type
Neoplasms
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on December 02, 2016