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

NCT02856204 | Completed

• 3 other identifiers: HEMAML0035NCI-2016-0112832817
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia; Febrile Neutropenia

Outcome Measures

Primary Outcomes (6)

• 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 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

  Up to 6 weeks

Study Arms (1)

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: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Interventions

Cytology Specimen Collection Procedure OTHER

Undergo collection of blood

Also known as: Cytologic Sampling

Diagnostic (collection of blood samples)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (collection of blood samples)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Prior history of febrile neutropenia

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Febrile Neutropenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Stanley Deresinski

  Stanford University

  PRINCIPAL INVESTIGATOR

• Steven Coutre

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

US (1)