RECRUITING

Symphony IL-6 Reference Range Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device. The objective of this study is to establish a reference range for Symphony IL-6 in a cohort of apparently healthy individuals.

Official Title

Symphony IL-6 Reference Range Study

Quick Facts

Study Start:2021-08-31
Study Completion:2024-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05048888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is willing and able to provide informed consent
  2. * \> 18 years of age
  3. * Whole blood specimen collected in EDTA anticoagulant tubes
  4. * Minimum volume of 100µL for Symphony IL-6 testing
  5. * Specimen is available for testing within 12 hours from collection
  6. * C-Reactive Protein (CRP) \< 10 mg/L
  1. * Subjects presenting with a fever
  2. * Subjects with a diagnosis of COVID-19 or other respiratory illness at the time of collection
  3. * Subjects otherwise self-reported as unhealthy
  4. * Hemolyzed specimens

Contacts and Locations

Study Contact

Jason Cook, PhD
CONTACT
844-327-7078
jason.cook@bluejaydx.com

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Bluejay Diagnostics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-31
Study Completion Date2024-03-30

Study Record Updates

Study Start Date2021-08-31
Study Completion Date2024-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Sepsis