The DISCOVER Trial (Diagnosis of Infection in Stem Cell T... | NCT02804464

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

NCT02804464

Sponsor

Karius, Inc.

Status

Unknown status

Last Update Posted

Mar 8, 2023Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Bone Marrow Transplant Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 2022Actual

Completion Date

Jul 2023Estimated

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Jun 14, 2016

First Posted Date

Jun 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2023

Last Update Posted Date

Mar 8, 2023Actual

Name	Class
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Chin-Hong, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided