Clinical trial NCT03606382: Collection of Clinical Specimens From Volunteers for Assay Development
Official title: Collection of Clinical Specimens From Volunteers for Assay Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Infection
Lead sponsor: Inflammatix
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer participants

Brief summary: This study will analyze gene expression data from various biological specimens collected from voluntary participants.

Detailed description: Primary objective is the collection of specimens from volunteers for the development and validation of HostDx tests. The study does only encompass specimen collection - Therefore, no traditional endpoint is defined but rather the successful collection of clinical specimens is defined as the endpoint.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* Able to provide informed consent

Exclusion Criteria:

* Known pregnancy
* Inability to understand instructions and comply with study related procedures

Primary outcomes:
measure: Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Inflammatix, Inc.
state: California
Study officials:
References:
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citation: Sweeney TE, Perumal TM, Henao R, Nichols M, Howrylak JA, Choi AM, Bermejo-Martin JF, Almansa R, Tamayo E, Davenport EE, Burnham KL, Hinds CJ, Knight JC, Woods CW, Kingsmore SF, Ginsburg GS, Wong HR, Parnell GP, Tang B, Moldawer LL, Moore FE, Omberg L, Khatri P, Tsalik EL, Mangravite LM, Langley RJ. A community approach to mortality prediction in sepsis via gene expression analysis. Nat Commun. 2018 Feb 15;9(1):694. doi: 10.1038/s41467-018-03078-2.
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