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

Fungemia Survey in Cancer Patients

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • Cologne, Germany, D-50931
        • German Hodgkin's Lymphoma Study Group
      • Genoa, Italy, 16132
        • Ospedale San Martino
      • Geneva, Switzerland, CH-1211
        • Hopital Cantonal Universitaire De Geneve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Oliver Cornely, German Hodgkin's Lymphoma Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

May 12, 2016

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EORTC-65031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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