Bone Marrow Transplant InfectionDISCOVERNCT02804464
The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
An observational study of Bone Marrow Transplant Infection, run by Karius, Inc. at 1 site in United States.
Trial summary
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Transplant Infection
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2023
- 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: Patients who are being evaluated for a stem-cell transplant at the University of California, San Francisco Hospital will be eligible for this study.
Who may be able to join
- 18 years of age or older
- Patients who plan on undergoing an allogeneic stem cell transplant and are admitted to UCSF Medical Center.
Who cannot join
- Inability to provide informed consent and comply with study-related procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics
- Conditions
- Bone Marrow Transplant Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2022
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Transplant InfectionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karius, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Peter Chin-Hong, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804464
- Sponsor's protocol ID
- 002-CL-01
- Acronym
- DISCOVER
- Status last verified
- Mar 2023
- First submitted
- 14 Jun 2016
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
- ClinicalTrials.gov ID
- NCT02804464
- Acronym / sponsor ID
- DISCOVER / 002-CL-01
- Conditions
- Bone Marrow Transplant Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karius, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- Jul 2016
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2023 (estimated)
- First posted
- 17 Jun 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.
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are being evaluated for a stem-cell transplant at the University of California, San Francisco Hospital will be eligible for this study.
Key inclusion criteria (2 listed)
- 18 years of age or older
- Patients who plan on undergoing an allogeneic stem cell transplant and are admitted to UCSF Medical Center.
Key exclusion criteria (1 listed)
- Inability to provide informed consent and comply with study-related procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Peter Chin-Hong, MD principal investigator
University of California, San Francisco
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 Bone Marrow Transplant Infection, run by Karius, Inc. 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. 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?
Results are not available in the source record.
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?
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard clinical diagnostics. (time frame: 7 days). 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 8 Mar 2023.