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

May 14, 2019 updated by: Stanford University

Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior history of febrile neutropenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic (collection of blood samples)
Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Cytology Specimen Collection Procedure
Undergo collection of blood
Other Names:
  • Cytologic Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 weeks
Number and frequency of novel pathogens found
Time Frame: Up to 6 weeks
Up to 6 weeks
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
Up to 6 weeks
Proportion of patients with false negative
Time Frame: Up to 6 weeks
Up to 6 weeks
Proportion of patients with false positives
Time Frame: Up to 6 weeks
Up to 6 weeks
Proportion of patients with mitochondrial DNA detected
Time Frame: Up to 6 weeks
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Up to 6 weeks
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Stanley Deresinski, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMAML0035
  • NCI-2016-01128 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 32817 (Other Identifier: Stanford IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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