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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01128 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 32817 | Other Identifier | Stanford IRB |
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This research trial studies the shotgun sequencing of blood samples in diagnosing febrile neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help identify pathogens and accurately diagnose infections such as febrile neutropenia.
PRIMARY OBJECTIVES:
I. To test the hypothesis that shotgun metagenomics is not inferior to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.
SECONDARY OBJECTIVES:
I. To establish a microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis.
OUTLINE:
Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (collection of blood samples) | Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Undergo collection of blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of pathogens in patients with febrile neutropenia assessed by shotgun metagenomics | Will be compared to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia. | Up to 6 weeks |
| Number and frequency of novel pathogens found | Up to 6 weeks | |
| Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen | Up to 6 weeks | |
| Proportion of patients with false negative | Up to 6 weeks | |
| Proportion of patients with false positives | Up to 6 weeks | |
| Proportion of patients with mitochondrial DNA detected | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis assessed by shotgun metagenomics | Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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hospitalized patients (at Stanford Hospital and Clinics) with acute myelogenous leukemia (AML), who are expected to have neutropenia (defined as absolute neutrophil count < 500 / cubic mm) lasting ≥ 7 days after chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Deresinski | Stanford University | Principal Investigator |
| Steven Coutre | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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blood samples
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |