Tuberculosis (TB)NCT04243031
QuantiFERON Access Clinical Performance Study Protocol
An observational study of Tuberculosis (TB), run by QIAGEN Gaithersburg, Inc.
Trial summary
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- QFT Access
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Nov 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: Participants coming to clinic
Who may be able to join
- 1. Be ≥ 18 years of age,
- 2. Have received no TB treatment or received treatment for less than 14 consecutive days.
- 3. Provide Informed Consent.
Who cannot join
- 1. They do not meet the inclusion criteria,
- 2. Blood handling was not completed using QFT-Plus
- 3. Incubation was <16 and >24 hours
- 4. Improperly collected and/or stored samples per Instructions For Use
About this study
Official title: A Non-interventional, Prospective Clinical Performance Study of the QuantiFERON Access Kit to Demonstrate Clinical Accuracy Compared to a CE-marked In-Vitro Diagnostic Medical Device, in Participants With Varying Risk Factors for TB Infection and Disease.
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Conditions
- Tuberculosis (TB)
- Being tested
- QFT Access
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFT AccessDevice
Measure of Interferon Gamma
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Those with TB and those without TB. Receives: Device: QFT Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB Result
QFT Access result compared to the QFT-Plus result (positive, negative)
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243031
- Sponsor's protocol ID
- TMF-17-1056-1
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Prospective Clinical Performance Study of the QuantiFERON Access Kit to Demonstrate Clinical Accuracy Compared to a CE-marked In-Vitro Diagnostic Medical Device, in Participants With Varying Risk Factors for TB Infection and Disease.
- ClinicalTrials.gov ID
- NCT04243031
- Acronym / sponsor ID
- TMF-17-1056-1
- Conditions
- Tuberculosis (TB)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 27 Jan 2020 (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.
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: QFT AccessThose with TB and those without TB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants coming to clinic
Key inclusion criteria (3 listed)
- 1. Be ≥ 18 years of age,
- 2. Have received no TB treatment or received treatment for less than 14 consecutive days.
- 3. Provide Informed Consent.
Key exclusion criteria (4 listed)
- 1. They do not meet the inclusion criteria,
- 2. Blood handling was not completed using QFT-Plus
- 3. Incubation was <16 and >24 hours
- 4. Improperly collected and/or stored samples per Instructions For Use
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 |
|---|---|---|
| QFT AccessMeasure of Interferon Gamma | Device | All subjects |
Primary outcome
TB Result
Time frame: At time of enrollment
QFT Access result compared to the QFT-Plus result (positive, negative)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis (TB), run by QIAGEN Gaithersburg, Inc.
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 4 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: withdrawn, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
TB Result (time frame: At time of enrollment). 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 Sep 2020.