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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

304 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2016-05-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fungemia in Hematologic Malignancies

NCT02451592

Acute Leukemia Chronic Leukemia Multiple Myeloma +1 more

COMPLETED

Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients

NCT06392581

Acute Lymphoblastic Leukemia

RECRUITING

Early Diagnosis of Aspergillosis in Patients at High Risk of Fungal Infection Caused by Treatment for Hematologic Cancer or Other Disease

NCT00462657

Graft Versus Host Disease Infection Leukemia +2 more

UNKNOWN NA

Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy

NCT03221075

Invasive Aspergillosis

COMPLETED

Diagnostic Study of Combined Biomnarker Testing in Bronchoalveolar Lavage Samples of Immunocompromised Patients

NCT01695512

Invasive Aspergillosis Acute Leukemia Biomarkers +1 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

clinical observation

Intervention Type OTHER

management of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No