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

Acute Myeloid Leukemia Clinical Trial

Official title:

Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856204
• Other study ID #: HEMAML0035
• Secondary ID: NCI-2016-0112832
• Status: Completed
• Start date: August 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with febrile neutropenia

• A primary diagnosis of acute myeloid leukemia (AML)

Exclusion Criteria:

• Prior history of febrile neutropenia

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Febrile Neutropenia
• Fever
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neutropenia

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo collection of blood
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number and frequency of novel pathogens found		Up to 6 weeks
Primary	Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen		Up to 6 weeks
Primary	Proportion of patients with false negative		Up to 6 weeks
Primary	Proportion of patients with false positives		Up to 6 weeks
Primary	Proportion of patients with mitochondrial DNA detected		Up to 6 weeks
Secondary	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