Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

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 July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 7, 2007
Last updated: May 14, 2011
Last verified: July 2009

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.

Condition Intervention
Other: clinical observation
Procedure: management of therapy complications

Study Type: Observational
Official Title: Fungemia Survey in Cancer Patients

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Relative incidence of fungemia
  • Fungal species distribution
  • Survival in patients with fungemia
  • Mortality at 2, 4, and 12 weeks after diagnosis of fungemia

Estimated Enrollment: 300
Study Start Date: February 2005
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Male or female
  • Menopausal status not specified


  • See Disease Characteristics
  • No prior participation in this study
  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 identifier: NCT00445952

Institut Jules Bordet
Brussels, Belgium, 1000
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
German Hodgkin's Lymphoma Study Group
Cologne, Germany, D-50931
Ospedale San Martino
Genoa, Italy, 16132
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Oliver Cornely German Hodgkin's Lymphoma Study Group
  More Information Identifier: NCT00445952     History of Changes
Other Study ID Numbers: CDR0000423221
Study First Received: March 7, 2007
Last Updated: May 14, 2011

Keywords provided by National Cancer Institute (NCI):
breast cancer in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
male breast cancer
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
unspecified adult solid tumor, protocol specific
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
stage IV chronic lymphocytic leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia processed this record on May 25, 2017