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

Stanford University

Status: Completed

Conditions: Febrile Neutropenia; Acute Myeloid Leukemia

Treatments: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

Study type: Observational

Funder types: Other

Identifiers

NCT02856204

HEMAML0035

32817 (Other Identifier)

NCI-2016-01128 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Prior history of febrile neutropenia

Trial design

56 participants in 1 patient group

Diagnostic (collection of blood samples)

Description:

Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Cytology Specimen Collection Procedure