Bone Marrow Transplant Infection Clinical Trial
— DISCOVEROfficial title:
The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
| NCT number | NCT02804464 |
| Other study ID # | 002-CL-01 |
| Secondary ID | |
| Status | Active, not recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2016 |
| Est. completion date | July 2023 |
| Verified date | March 2023 |
| Source | Karius, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Active, not recruiting |
| Enrollment | 70 |
| Est. completion date | July 2023 |
| Est. primary completion date | July 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, San Francisco | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Karius, Inc. | University of California, San Francisco |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 7 days |
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