HealthyPRO-HNCT02591121
Procalcitonin Test Reference Range Determination
An observational study of Healthy, run by Response Biomedical Corp. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 125 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy normal
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Currently pregnant or nursing a child
- Unable, or unwilling, to provide required blood sample for testing
- Non-compliance to the protocol or inclusion criteria
- Investigator believes subject is unsuitable for inclusion in the trial (i.e. has major condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation To Determine The Expected Values Distribution Of Procalcitonin For The RAMP® Procalcitonin Test In A Healthy Reference Population (PRO-H)
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.
Read the detailed description
Healthy volunteers who meet eligibility criteria and have provided informed consent will be enrolled in this study. Each participant will be required to donate 1 blood sample via standard venipuncture into an EDTA (lavender top) tube for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. Sample collection will take place within a single clinical session. The maximum trial duration for each participant is one clinic session.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Response Biomedical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Azar Azad, Principal investigator, Mount Sinai Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591121
- Sponsor's protocol ID
- CSP025
- Acronym
- PRO-H
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation To Determine The Expected Values Distribution Of Procalcitonin For The RAMP® Procalcitonin Test In A Healthy Reference Population (PRO-H)
- ClinicalTrials.gov ID
- NCT02591121
- Acronym / sponsor ID
- PRO-H / CSP025
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Response Biomedical Corp.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Healthy volunteers who meet eligibility criteria and have provided informed consent will be enrolled in this study. Each participant will be required to donate 1 blood sample via standard venipuncture into an EDTA (lavender top) tube for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. Sample collection will take place within a single clinical session. The maximum trial duration for each participant is one clinic session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy normal
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procalcitonin value for healthy reference subjects
Time frame: Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azar Azad principal investigator
Mount Sinai Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Response Biomedical Corp. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procalcitonin value for healthy reference subjects (time frame: Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.