Shotgun Sequencing in Diagnosing Febrile Neutropenia in Patients With Acute Myeloid Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia

Conditions
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Acute Myeloid Leukemia, Febrile Neutropenia

Intervention / Treatment
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* Other: Cytology Specimen Collection Procedure
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with febrile neutropenia A primary diagnosis of acute myeloid leukemia (AML) Exclusion Criteria: Prior history of febrile neutropenia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (collection of blood samples)<br>Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks. | Other: Cytology Specimen Collection Procedure<br>* Undergo collection of blood<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |