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

European Organisation for Research and Treatment of Cancer (EORTC)

Status: Completed

Conditions: Cancer

Treatments: Other: clinical observation; Procedure: management of therapy complications

Study type: Observational

Funder types: NETWORK

Identifiers

NCT00445952

EORTC-65031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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