TuberculosisNCT04141982
Clinical Concordance Evaluation of T-SPOT®.TB Assay Performance (T-Cell SelectTM Study)
An observational study of Tuberculosis, run by Oxford Immunotec at 4 sites in 2 countries.
Trial summary
The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- T-Cell SelectTM Kit
- How many people
- 680 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Nov 2019to 18 Mar 2020
- 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: This evaluation will collect blood samples from subjects suspected of having TB infection and, samples from a low risk control population with no (or minimal) TB risk factors. All subjects presenting at participating clinics will be eligible for enrolment into the study provided they meet the inclusion/exclusion criteria outlined in section 4. Based on previous experience and the medical profile of the patient attending each of clinics at the four study sites, it is expected that the sites will individually, and collectively, yield a range of positive and negative assay results required to assess the impact of the T-Cell Select kit on positive and negative agreements of the T-SPOT.TB test.
Who may be able to join
None listed.
Who cannot join
- Unable to meet inclusion criteria
- Subjects presenting at sites enrolling "no (or minimal) TB risk factors" population Inclusion Criteria
- Be able to provide informed consent
- Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
- Have no suspicion TB infection.
- Be at least 18 years of age.
Show all 16Show fewer
- Live in low endemic area for TB infection
- Have no previous medical record of TB infection
- Unable to meet inclusion criteria
- Current/previous TB diagnosis
- Subjects presenting at sites enrolling "low/intermediate TB risk factors" population Inclusion Criteria
- Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
- Have no suspicion TB infection.
- Be at least 18 years of age.
- Live in an low/intermediate endemic area for TB infection Exclusion Criteria
- Unable to meet inclusion criteria
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Texas Health Science Center at Houston, School of Public Health in Brownsville
Brownsville, Texas, 78520
Ohio State University
Columbus, Ohio, 43210
NECCR Primacare Research, LLC
Fall River, Massachusetts, 02721
About this study
Official title: Clinical Concordance Evaluation of the T-SPOT®.TB Assay Performance Using Positive Selection With the T-Cell SelectTM Kit and Density Gradient Cell Isolation Methods
The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture
Read the detailed description
In this study, clinical concordance between results of the T-SPOT.TB assay, using cells stored for 0-8 hours post venepuncture and isolated via density gradient separation and positive selection with magnetic bead isolation using the T-Cell SelectTM Kit will be assessed. Concordance between results of the T-SPOT.TB assay at 0-8 hours post venepuncture and using cells isolated with density gradient centrifugation and results obtained from cells isolated using the T-Cell Select Kit, following storage between 0-55 hours post venepuncture, will be assessed.
- Conditions
- Tuberculosis
- Being tested
- T-Cell SelectTM Kit
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Cell SelectTM KitDiagnostic test
The T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay.
| Study group | Role | What they receive |
|---|---|---|
| Suspected of having TB infection | These donors are suspected of having TB infection and live in a high endemic area for TB infection Receives: Diagnostic Test: T-Cell SelectTM Kit | |
| No (or minimal) TB risk factors | These donors must have no previous medical record of TB infection and live in low endemic area for TB infection Receives: Diagnostic Test: T-Cell SelectTM Kit | |
| low/intermediate risk of TB infection population | These donors must live in an low/intermediate endemic area for TB infection Receives: Diagnostic Test: T-Cell SelectTM Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture
Achieving 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start4 Nov 2019
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Immunotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre Trollip, PhD, Principal investigator, RapitradeBlanca Restrepo, PhD, Principal investigator, The University of Texas Health Science Center, HoustonEhab Sorial, MD, Principal investigator, NECCR Primacare Research, LLCShu-Hua Wang, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141982
- Sponsor's protocol ID
- OI-18-01-IP-0001
- Status last verified
- Mar 2022
- First submitted
- 25 Oct 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Concordance Evaluation of the T-SPOT®.TB Assay Performance Using Positive Selection With the T-Cell SelectTM Kit and Density Gradient Cell Isolation Methods
- ClinicalTrials.gov ID
- NCT04141982
- Acronym / sponsor ID
- OI-18-01-IP-0001
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Oxford ImmunotecIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 28 Oct 2019 (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.
The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture
Detailed description
In this study, clinical concordance between results of the T-SPOT.TB assay, using cells stored for 0-8 hours post venepuncture and isolated via density gradient separation and positive selection with magnetic bead isolation using the T-Cell SelectTM Kit will be assessed. Concordance between results of the T-SPOT.TB assay at 0-8 hours post venepuncture and using cells isolated with density gradient centrifugation and results obtained from cells isolated using the T-Cell Select Kit, following storage between 0-55 hours post venepuncture, will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected of having TB infection | – | Diagnostic Test: T-Cell SelectTM KitThese donors are suspected of having TB infection and live in a high endemic area for TB infection |
| No (or minimal) TB risk factors | – | Diagnostic Test: T-Cell SelectTM KitThese donors must have no previous medical record of TB infection and live in low endemic area for TB infection |
| low/intermediate risk of TB infection population | – | Diagnostic Test: T-Cell SelectTM KitThese donors must live in an low/intermediate endemic area for TB infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This evaluation will collect blood samples from subjects suspected of having TB infection and, samples from a low risk control population with no (or minimal) TB risk factors. All subjects presenting at participating clinics will be eligible for enrolment into the study provided they meet the inclusion/exclusion criteria outlined in section 4. Based on previous experience and the medical profile of the patient attending each of clinics at the four study sites, it is expected that the sites will individually, and collectively, yield a range of positive and negative assay results required to assess the impact of the T-Cell Select kit on positive and negative agreements of the T-SPOT.TB test.
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Unable to meet inclusion criteria
- Subjects presenting at sites enrolling "no (or minimal) TB risk factors" population Inclusion Criteria
- Be able to provide informed consent
- Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
- Have no suspicion TB infection.
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 |
|---|---|---|
| T-Cell SelectTM KitThe T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay. | Diagnostic test | No (or minimal) TB risk factors, Suspected of having TB infection, low/intermediate risk of TB infection population |
Primary outcome
Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture
Time frame: 1 year
Achieving 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture
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 3 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Andre Trollip, PhD principal investigator
Rapitrade
Blanca Restrepo, PhD principal investigator
The University of Texas Health Science Center, Houston
Ehab Sorial, MD principal investigator
NECCR Primacare Research, LLC
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Oxford Immunotec at 4 sites in 2 countries.
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 0 inclusion and 16 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, South Africa. 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?
Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture (time frame: 1 year). 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 3 Mar 2022.