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NCT Number: NCT00445952

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

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.

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Key information

Conditions

Cancer Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Burkitt Lymphoma Carcinogenesis Carcinoma Carcinoma in Situ Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Epstein-Barr Virus Infections Eye Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Intraocular Lymphoma Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lung Diseases Lung Neoplasms Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Mycosis Fungoides Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Plasma Cell Neoplastic Processes Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Polycythemia Vera Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Respiratory Tract Diseases Respiratory Tract Neoplasms Sezary Syndrome Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Jules Bordet, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clinical observation

Other

management of therapy complications

Procedure

Primary outcomes

  1. Relative incidence of fungemia

  2. Fungal species distribution

  3. Survival in patients with fungemia

  4. Mortality at 2, 4, and 12 weeks after diagnosis of fungemia

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study title

Fungemia Survey in Cancer Patients

Important dates

Study start
2005
Primary completion
2009
Study completion
2016
First posted
Mar 9, 2007
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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