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 because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00445952
First received: March 7, 2007
Last updated: May 14, 2011
Last verified: July 2009
  Purpose

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
Cancer
Other: clinical observation
Procedure: management of therapy complications

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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Lymphoma, Small Cleaved-cell, Diffuse Multiple Myeloma Chronic Myeloproliferative Disorders Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Hodgkin Lymphoma Waldenstrom Macroglobulinemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Acute Myeloid Leukemia, Adult Follicular Lymphoma B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Lymphoma, Large-cell Lymphomatoid Granulomatosis Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Lymphoblastic Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Hypereosinophilic Syndrome Monoclonal Gammopathy of Undetermined Significance Central Nervous System Lymphoma, Primary Mantle Cell Lymphoma Cutaneous T-cell Lymphoma Breast Cancer, Male AL Amyloidosis Polycythemia Vera Essential Thrombocythemia Leukemia, T-cell, Chronic Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Anaplastic Plasmacytoma Large Granular Lymphocyte Leukemia
U.S. FDA Resources

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00445952

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
France
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Germany
German Hodgkin's Lymphoma Study Group
Cologne, Germany, D-50931
Italy
Ospedale San Martino
Genoa, Italy, 16132
Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Oliver Cornely German Hodgkin's Lymphoma Study Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00445952     History of Changes
Other Study ID Numbers: CDR0000423221, EORTC-65031
Study First Received: March 7, 2007
Last Updated: May 14, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014