NCT02804464

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

6 years

First QC Date

June 14, 2016

Last Update Submit

March 7, 2023

Conditions

Bone Marrow Transplant Infection

Outcome Measures

Primary Outcomes (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.

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

Study Officials

  • Peter Chin-Hong, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

US(1)