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The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time) (DISCOVER)

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ClinicalTrials.gov Identifier: NCT02804464
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Karius, Inc.

Brief 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

Condition or disease
Bone Marrow Transplant Infection

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
Study Start Date : July 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019



Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Patients who plan on undergoing an allogeneic stem cell transplant and are admitted to UCSF Medical Center.

Exclusion Criteria:

  • Inability to provide informed consent and comply with study-related procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804464


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Karius, Inc.
University of California, San Francisco
Investigators
Principal Investigator: Peter Chin-Hong, MD University of California, San Francisco

Responsible Party: Karius, Inc.
ClinicalTrials.gov Identifier: NCT02804464     History of Changes
Other Study ID Numbers: 002-CL-01
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Infection
Communicable Diseases