Procalcitonin Test Reference Range Determination

NCT02591121 | Completed

• 1 other identifier: CSP025
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, single-centre study in healthy volunteers to establish a reference range for the RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the reference range for measurement of PCT levels using the RAMP Procalcitonin test.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Procalcitonin value for healthy reference subjects

  Procalcitonin value for each subject will be determined within 2 hours of phlebotomy. At study completion all data obtained will be compiled and a 95th percentile value determined.

  Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy normal

You may qualify if:

• Apparently healthy (as determined by a subject questionnaire) males or females, of any race
• \>18 years of age
• Willing to voluntarily agree to sign a consent form

You may not qualify if:

• Meets the definition for one or more of Systematic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock and/or Multiple Organ Dysfunction Syndrome (MODS) as defined by The American College of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM) consensus conference in 1992.
• Current diagnosis, or history, of any underlying major medical condition such as heart disease, hypertension/hypotension, stroke, renal disease, chronic obstructive pulmonary disorder, diabetes, bleeding disorders, hypercalcitoninemia, HIV, etc.
• Bacterial, fungal or malaria infection within previous 12 months
• Have experienced or undergone trauma, surgery, cardiac shock and/or a burn within previous 3 months
• Current diagnosis of cancer and/or has undergone Immunotherapy which stimulates cytokines in the previous 12 months
• Hospitalization (for \>24 hours) within previous 3 months
• Currently pregnant or nursing a child
• Unable, or unwilling, to provide required blood sample for testing

Sponsors & Collaborators

• Response Biomedical Corp.: lead

Study Sites (1)

Mt. Sinai Hospital

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

• Azar Azad

  Mount Sinai Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 16, 2015

Record last verified: 2015-10

Locations

CA (1)