Natural History Study of Fungal Infections of the Blood in Patients With Cancer or in Patients Who Have Undergone a Stem Cell Transplant

Cancer Clinical Trial

Official title:

Fungemia Survey in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445952
• Other study ID #: EORTC-65031
• Secondary ID: EORTC-65031
• Status: Completed
• Phase: N/A
• First received: March 7, 2007
• Last updated: January 31, 2018
• Start date: February 2005
• Est. completion date: May 12, 2016

Study information

• Verified date: January 2018
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease.

PURPOSE: This natural history study is collecting information about fungal infections of the blood over time from patients with cancer or from patients who have undergone a stem cell transplant.

Description:

OBJECTIVES:

• Determine the incidence of fungemia in relation to the number of admissions to the hospital in patients with solid tumor or hematologic malignancy or in patients who have undergone hematopoietic stem cell transplantation.

• Determine the fungal species distribution, prognostic factors for outcome, and crude and attributable mortality in patients also diagnosed with fungemia.

OUTLINE: This is a multicenter, nonrandomized, prospective study.

• Group A (no documented fungemia at study entry): Data regarding the number of patients with cancer or who have undergone hematopoietic stem cell transplantation, including those who develop documented fungemia, who are admitted to the hospital is collected for 2 years.

• Group B (documented fungemia at study entry): Fungal strains isolated from the initial positive blood culture are collected and undergo examination, including confirmation of species identification, susceptibility testing, and/or minimum inhibitory concentration determination. Data, including antifungal treatment, clinical and microbiological response to antifungal treatment (at 2, 4, and 12 weeks after diagnosis), and survival status, is collected for each documented fungemia episode* for up to 12 weeks after diagnosis of fungemia.

NOTE: *That occurs within a 2-year period.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: May 12, 2016
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Group A:

• Meets any of the following criteria:

• Diagnosis of hematological malignancy including, but not limited to, any of the following:

• Acute lymphoblastic leukemia

• Acute myeloid leukemia

• Myelodysplastic syndromes

• Chronic lymphocytic leukemia

• Diagnosis of solid tumor, including, but not limited to, any of the following:

• Breast cancer (hormone receptor status not specified)

• Lung cancer

• Colon cancer

• Recipient of a hematopoietic stem cell transplantation, including, but not limited to, any of the following:

• Allogeneic or autologous bone marrow transplantation

• Peripheral blood stem cell transplantation

• Admitted to a participating hospital ward (defined as = 1 overnight stay)

• Group B:

• Meets the same criteria as in group A

• Positive blood culture for a fungus

PATIENT CHARACTERISTICS:

• Male or female

• Menopausal status not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior participation in this study

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• clinical observation

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
France	CHU de Grenoble - Hopital de la Tronche	Grenoble
Germany	German Hodgkin's Lymphoma Study Group	Cologne
Italy	Ospedale San Martino	Genoa
Switzerland	Hopital Cantonal Universitaire de Geneve	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative incidence of fungemia
Primary	Fungal species distribution
Primary	Survival in patients with fungemia
Primary	Mortality at 2, 4, and 12 weeks after diagnosis of fungemia