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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00445952
  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
Procedure: management of therapy complications
Procedure: observation

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Fungal Infections    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lung Cancer    Lymphoma    Molds    Multiple Myeloma   

Drug Information available for:   Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445952

Locations
Germany
German Hodgkin's Lymphoma Study Group     Recruiting
      Cologne, Germany, D-50931
      Contact: Oliver Cornely     49-22-1478-6494     oliver.cornely@uni-koeln.de    
Italy
Ospedale San Martino     Recruiting
      Genoa, Italy, 16132
      Contact: Contact Person     39-10-560-0665        
Switzerland
Hopital Cantonal Universitaire de Geneve     Recruiting
      Geneva, Switzerland, CH-1211
      Contact: Contact Person     41-22-372-4018        

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Oliver Cornely     German Hodgkin's Lymphoma Study Group    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000423221, EORTC-65031
First Received:   March 7, 2007
Last Updated:   October 16, 2008
ClinicalTrials.gov Identifier:   NCT00445952
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Polycythemia
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Lymphomatoid granulomatosis
Mycoses
Preleukemia
Leukemia, Prolymphocytic
Multiple myeloma
Lung Neoplasms
Hemorrhagic thrombocythemia
Neoplasm Metastasis
Lymphoma, Large-Cell, Anaplastic
Thrombocythemia, Hemorrhagic
Acute myeloid leukemia, adult
Hodgkin Disease
Essential thrombocytosis
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Non-small cell lung cancer
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, B-cell, chronic

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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