Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445952
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2007-03-07
Brief Title:
Natural History Study of Fungal Infections of the Blood in Patients With Cancer or in Patients Who Have Undergone a Stem Cell Transplant
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Fungemia Survey in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-65031 | None | None | None |