HealthyNCT03319446
Collection of Anonymized Samples
An observational study of Healthy and Respiratory Disease, run by BioFire Diagnostics, LLC at 1 site in United States.
Trial summary
This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. Subjects will be recruited from BioFire Diagnostics employees and from the general community. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Healthy, Respiratory Disease, Gastrointestinal Disease
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Adult, Older adult
Study population: Employees of BioFire Diagnostics, and the general community of the greater Salt Lake City area.
Who may be able to join
- Consenting adult
Who cannot join
- Weigh less that 110 lb for blood collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Collection of Anonymized Samples for Use in Product Development and Clinical Trials
This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. Subjects will be recruited from BioFire Diagnostics employees and from the general community. Subjects may be asked about recent or ongoing illness at the time of specimen collection and these symptoms will be recorded and attached to the sample. No other identifying information will be collected and the samples will be kept anonymous.The samples may be used internally or by external sites, such as the clinical study sites, for evaluating and determining performance characteristics of in vitro diagnostic devices.
- Conditions
- Healthy, Respiratory Disease, Gastrointestinal Disease
- Medical subject headings
- Respiration Disorders, Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR Amplification Curves
PCR amplification curves will be used to confirm the presence or absence of target analytes.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start9 Oct 2017
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioFire Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319446
- Sponsor's protocol ID
- DX-SDY-036556
- Status last verified
- Oct 2017
- First submitted
- 18 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Anonymized Samples for Use in Product Development and Clinical Trials
- ClinicalTrials.gov ID
- NCT03319446
- Acronym / sponsor ID
- DX-SDY-036556
- Conditions
- Healthy, Respiratory Disease, Gastrointestinal Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- BioFire Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Oct 2017 (actual)
- 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.
This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. Subjects will be recruited from BioFire Diagnostics employees and from the general community. Subjects may be asked about recent or ongoing illness at the time of specimen collection and these symptoms will be recorded and attached to the sample. No other identifying information will be collected and the samples will be kept anonymous.The samples may be used internally or by external sites, such as the clinical study sites, for evaluating and determining performance characteristics of in vitro diagnostic devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Employees of BioFire Diagnostics, and the general community of the greater Salt Lake City area.
Key inclusion criteria (1 listed)
- Consenting adult
Key exclusion criteria (1 listed)
- Weigh less that 110 lb for blood collection
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
PCR Amplification Curves
Time frame: 10 years
PCR amplification curves will be used to confirm the presence or absence of target analytes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Respiratory Disease, run by BioFire Diagnostics, LLC at 1 site in United States.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 24 Oct 2017. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
PCR Amplification Curves (time frame: 10 years). 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 24 Oct 2017.