DengueNCT01656174
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross
An observational study of Dengue, run by Gen-Probe, Incorporated at 2 sites in United States.
Trial summary
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Procleix Dengue Virus Assay
- Type of treatment
- Medical device
- How many people
- 35,035 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: volunteer blood donors from Puerto Rico
Who may be able to join
- Donor must meet all the blood collection sites' standard eligibility requirements.
- Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
American Red Cross National Testing Laboratory
Charlotte, North Carolina, 28273
Creative Testing Solutions
Tempe, Arizona, 85282
About this study
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.
- Conditions
- Dengue
- Being tested
- Procleix Dengue Virus Assay
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procleix Dengue Virus AssayDevice
in vitro diagnostic assay
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | Not described Receives: Device: Procleix Dengue Virus Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.
Measured: Approximately three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- 35,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gen-Probe, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renee Wait, Study director, Gen-Probe, Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656174
- Sponsor's protocol ID
- DENVTS-US12-001
- Status last verified
- Mar 2015
- First submitted
- 31 Jul 2012
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross
- ClinicalTrials.gov ID
- NCT01656174
- Acronym / sponsor ID
- DENVTS-US12-001
- Conditions
- Dengue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,035 participants (actual)
- Lead sponsor
- Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Aug 2012 (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.
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | Device: Procleix Dengue Virus Assay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- volunteer blood donors from Puerto Rico
Key inclusion criteria (2 listed)
- Donor must meet all the blood collection sites' standard eligibility requirements.
- Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procleix Dengue Virus Assayin vitro diagnostic assay | Device | No Treatment |
Primary outcome
Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.
Time frame: Approximately three years
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 20 Mar 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.
Renee Wait study director
Gen-Probe, Incorporated
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Gen-Probe, Incorporated at 2 sites 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 2 inclusion and 0 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 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. (time frame: Approximately three 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 20 Mar 2015.