Acute Myeloid LeukemiaNCT02856204
Shotgun Sequencing in Diagnosing Febrile Neutropenia in Patients With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia and Febrile Neutropenia, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Febrile Neutropenia
- What is being tested?
- Cytology Specimen Collection Procedure and Laboratory Biomarker Analysis
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with febrile neutropenia
- A primary diagnosis of acute myeloid leukemia (AML)
Who cannot join
- Prior history of febrile neutropenia
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Acute Myeloid Leukemia, Febrile Neutropenia
- Being tested
- Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis
- Medical subject headings
- Leukemia, Myeloid, Acute, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Undergo collection of blood
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (collection of blood samples) | Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
Number and frequency of novel pathogens found
Measured: Up to 6 weeks
Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen
Measured: Up to 6 weeks
Proportion of patients with false negative
Measured: Up to 6 weeks
Proportion of patients with false positives
Measured: Up to 6 weeks
Proportion of patients with mitochondrial DNA detected
Measured: 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
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley Deresinski, Principal investigator, Stanford UniversitySteven Coutre, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856204
- Sponsor's protocol ID
- HEMAML0035
- Other IDs
- NCI-2016-01128, 32817
- Status last verified
- May 2019
- First submitted
- 2 Aug 2016
- Last updated
- 16 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT02856204
- Acronym / sponsor ID
- HEMAML0035
- Conditions
- Acute Myeloid Leukemia, Febrile Neutropenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (collection of blood samples) | – | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker AnalysisPatients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with febrile neutropenia
- A primary diagnosis of acute myeloid leukemia (AML)
Key exclusion criteria (1 listed)
- Prior history of febrile neutropenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingUndergo collection of blood | Other | Diagnostic (collection of blood samples) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (collection of blood samples) |
Primary outcome
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.
Number and frequency of novel pathogens found
Time frame: 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
Proportion of patients with false negative
Time frame: Up to 6 weeks
Proportion of patients with false positives
Time frame: Up to 6 weeks
Proportion of patients with mitochondrial DNA detected
Time frame: Up to 6 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley Deresinski principal investigator
Stanford University
Steven Coutre principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Febrile Neutropenia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of pathogens in patients with febrile neutropenia assessed by shotgun metagenomics (time frame: Up to 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.