Human T-Lymphotrophic Virus Type I and/or Type IINCT01149837
Evaluation of InnoLIA HTLV I/II Score
An observational study of Human T-Lymphotrophic Virus Type I and/or Type II, run by Creative Testing Solutions at 1 site in United States.
Trial summary
The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is intended as a supplemental test for blood donor samples that are reactive in routine anti-HTLV screening tests. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human T-Lymphotrophic Virus Type I and/or Type II
- What is being tested?
- InnoLIA HTLV I/II Score line immunoassay
- Type of treatment
- Medical device
- How many people
- 3,305 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 25 Jan 2019
- 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: Whole blood and HCT/P donor samples found repeatedly reactive for anti-HTLV-I/II using an FDA approved donor screening test
Who may be able to join
- Subjects completing a health history evaluation for routine donor screening
- Subjects willing and able to provide informed consent
- Subjects testing repeat reactive on a licensed screening test for HTLV antibodies
Who cannot join
- Subjects not meeting health history criteria for routine donor screening
- Subjects unwilling and unable to provide informed consent
- Subjects testing negative on a licensed screening test for HTLV antibodies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Diagnostic Study for Supplemental Testing of Anti-HTLV-I/II Reactive Human Blood Specimens
The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is intended as a supplemental test for blood donor samples that are reactive in routine anti-HTLV screening tests. This study will determine if the test is useful for donor counseling purposes.
Read the detailed description
The InnoLIA HTLV I/II Score study consists of three sub-studies. The first sub-study will determine the sensitivity, specificity and accuracy of HTLV type assignment using well-characterized samples from the NIH-funded HTLV Outcomes Study (HOST). The second sub-study will compare automated reading and interpretation of test results with manual reading and interpretation using a sub-set of samples tested in the initial study. The third sub-study allows for use of the InnoLIA HTLV I/II Score as a supplemental test for whole blood and HCT/P donors testing repeatedly reactive with an FDA-approved donor screening test for anti-HTLV-I/II.
- Being tested
- InnoLIA HTLV I/II Score line immunoassay
- Keywords
- HTLV, HTLV I, HTLV II, HTLV Type I and/or HTLV Type II antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnoLIA HTLV I/II Score line immunoassayDevice
This intervention consists of testing a residual serum or plasma sample from a blood donation or donor follow-up sample using the InnoLIA HTLV I/II Score line immunoassay
| Study group | Role | What they receive |
|---|---|---|
| residual blood donor samples | Protocol describes testing an HTLV-I/II antibody reactive population from this cohort using the InnoLIA HTLV I/II Score line immunoassay Receives: Device: InnoLIA HTLV I/II Score line immunoassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
INNO-LIA HTLV I/II Score Testing
322 residual donor samples tested
Measured: September 2013 through December 2013, up to 3 months
INNO-LIA HTLV I/II Score Testing
896 residual donor samples tested
Measured: January 2014 through December 2014, up to one year
INNO-LIA HTLV I/II Score Testing
630 residual donor samples tested
Measured: January 2015 through December 2015, up to one year
INNO-LIA HTLV I/II Score Testing
315 residual donor samples tested
Measured: January 2016 through May 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJul 2013
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human T-Lymphotrophic Virus Type I and/or Type IIStudies 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
- 3,305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creative Testing Solutions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phillip C Williamson, PhD, Principal investigator, Creative Testing Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149837
- Sponsor's protocol ID
- BB-IND 14309
- Status last verified
- Jan 2019
- First submitted
- 22 Jun 2010
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Diagnostic Study for Supplemental Testing of Anti-HTLV-I/II Reactive Human Blood Specimens
- ClinicalTrials.gov ID
- NCT01149837
- Acronym / sponsor ID
- BB-IND 14309
- Keywords
- HTLV, HTLV I, HTLV II, HTLV Type I and/or HTLV Type II antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,305 participants (actual)
- Lead sponsor
- Creative Testing SolutionsUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 24 Jun 2010 (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 InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is intended as a supplemental test for blood donor samples that are reactive in routine anti-HTLV screening tests. This study will determine if the test is useful for donor counseling purposes.
Detailed description
The InnoLIA HTLV I/II Score study consists of three sub-studies. The first sub-study will determine the sensitivity, specificity and accuracy of HTLV type assignment using well-characterized samples from the NIH-funded HTLV Outcomes Study (HOST). The second sub-study will compare automated reading and interpretation of test results with manual reading and interpretation using a sub-set of samples tested in the initial study. The third sub-study allows for use of the InnoLIA HTLV I/II Score as a supplemental test for whole blood and HCT/P donors testing repeatedly reactive with an FDA-approved donor screening test for anti-HTLV-I/II.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| residual blood donor samples | – | Device: InnoLIA HTLV I/II Score line immunoassayProtocol describes testing an HTLV-I/II antibody reactive population from this cohort using the InnoLIA HTLV I/II Score line immunoassay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Whole blood and HCT/P donor samples found repeatedly reactive for anti-HTLV-I/II using an FDA approved donor screening test
Key inclusion criteria (3 listed)
- Subjects completing a health history evaluation for routine donor screening
- Subjects willing and able to provide informed consent
- Subjects testing repeat reactive on a licensed screening test for HTLV antibodies
Key exclusion criteria (3 listed)
- Subjects not meeting health history criteria for routine donor screening
- Subjects unwilling and unable to provide informed consent
- Subjects testing negative on a licensed screening test for HTLV antibodies
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 |
|---|---|---|
| InnoLIA HTLV I/II Score line immunoassayThis intervention consists of testing a residual serum or plasma sample from a blood donation or donor follow-up sample using the InnoLIA HTLV I/II Score line immunoassay | Device | residual blood donor samples |
Primary outcome
INNO-LIA HTLV I/II Score Testing
Time frame: September 2013 through December 2013, up to 3 months
322 residual donor samples tested
INNO-LIA HTLV I/II Score Testing
Time frame: January 2014 through December 2014, up to one year
896 residual donor samples tested
INNO-LIA HTLV I/II Score Testing
Time frame: January 2015 through December 2015, up to one year
630 residual donor samples tested
INNO-LIA HTLV I/II Score Testing
Time frame: January 2016 through May 2016
315 residual donor samples tested
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 30 Jan 2019.
- Individual participant dataSharing planned: Undecided
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.
Phillip C Williamson, PhD principal investigator
Creative Testing Solutions
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 Human T-Lymphotrophic Virus Type I and/or Type II, run by Creative Testing Solutions 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 3 inclusion and 3 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 30 Jan 2019. 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?
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?
INNO-LIA HTLV I/II Score Testing (time frame: September 2013 through December 2013, up to 3 months). The study lists 4 primary outcomes in all. 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 30 Jan 2019.