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Completed

NCT Number: NCT02856204

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Histologic Type Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with febrile neutropenia
  • A primary diagnosis of acute myeloid leukemia (AML)

Exclusion criteria

  • Prior history of febrile neutropenia

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo collection of blood

Other names: Cytologic Sampling

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Detection of pathogens in patients with febrile neutropenia assessed by shotgun metagenomics

    Time frame: Up to 6 weeks

    Will be compared to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.

  2. Number and frequency of novel pathogens found

    Time frame: Up to 6 weeks

  3. Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen

    Time frame: Up to 6 weeks

  4. Proportion of patients with false negative

    Time frame: Up to 6 weeks

  5. Proportion of patients with false positives

    Time frame: Up to 6 weeks

  6. Proportion of patients with mitochondrial DNA detected

    Time frame: Up to 6 weeks

Secondary outcomes

  1. Microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis assessed by shotgun metagenomics

    Time frame: Up to 6 weeks

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Aug 4, 2016
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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