Natural History Study of Fungal Infections of the Blood i... | NCT00445952 | Trialant
NCT00445952
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Status
Completed
Last Update Posted
Feb 1, 2018Actual
Enrollment
304Actual
Phase
Not provided
Conditions
Cancer
Interventions
clinical observation
management of therapy complications
Countries
Belgium
France
Germany
Italy
Switzerland
Protocol Section
Identification Module
NCT ID
NCT00445952
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EORTC-65031
Secondary IDs
ID
Type
Description
Link
EORTC-65031
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
Official Title
Fungemia Survey in Cancer Patients
Acronym
Not provided
Organization
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
Status Module
Record Verification Date
Jan 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2005
Primary Completion Date
Nov 2009Actual
Completion Date
May 12, 2016Actual
First Submitted Date
Mar 7, 2007
First Submission Date that Met QC Criteria
Mar 7, 2007
First Posted Date
Mar 9, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 31, 2018
Last Update Posted Date
Feb 1, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
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.
Conditions Module
Conditions
Cancer
Keywords
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
No data available
No data is available for this block.
Biospecimen
No data available
No data is available for this block.
Enrollment
304Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
clinical observation
Other
management of therapy complications
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Relative incidence of fungemia
Fungal species distribution
Survival in patients with fungemia
Mortality at 2, 4, and 12 weeks after diagnosis of fungemia
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Oliver Cornely
German Hodgkin's Lymphoma Study Group
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Institut Jules Bordet
Brussels
1000
Belgium
CHU de Grenoble - Hopital de la Tronche
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma