Cell-mediated Immune ResponseNCT02416414
Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients
An observational study of Cell-mediated Immune Response, run by QIAGEN Gaithersburg, Inc at 4 sites in United States.
Trial summary
To compare the performance of the QuantiFERON Monitor assay against existing methodology. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cell-mediated Immune Response
- What is being tested?
- QuantiFERON Monitor Assay and Existing methodology
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2015to Feb 2016
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects who have either received a solid organ transplant or who are healthy.
Who may be able to join
- Provide Informed Consent
- Received a solid organ transplant
- Provide Informed Consent
Who cannot join
- Pregnancy or recent lactation (<1yr)
- Treatment of Rejection
- Healthy Control
- Currently taking any immunomodulatory medication
- A history of immunosuppressive disease or immunosuppression condition or history of autoimmune diseases
- Current pregnancy or recent lactation (<1yr)
- Currently taking antiviral medication
- Currently being treated for infectious diseases
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of California Los Angeles
Los Angeles, California, 90024
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
To compare the performance of the QuantiFERON Monitor assay against existing methodology.
- Conditions
- Cell-mediated Immune Response
- Being tested
- QuantiFERON Monitor Assay, Existing methodology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantiFERON Monitor AssayDevice
Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.
Existing methodologyDevice
Assay to measure cell-mediated immune function using existing methodology.
| Study group | Role | What they receive |
|---|---|---|
| Solid Organ Transplant Recipients | Subjects who have received a Solid Organ Transplant. Receives: Device: QuantiFERON Monitor Assay; Device: Existing methodology | |
| Healthy Controls | Healthy individuals. Receives: Device: QuantiFERON Monitor Assay; Device: Existing methodology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-mediated immune response.
Measured: 1 day (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 posted15 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Sponsor decided not to go forward with study for FDA submission.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell-mediated Immune ResponseStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camille N Kotton, M.D., Principal investigator, Transplant and Immunocompromised Host Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416414
- Sponsor's protocol ID
- CST007_10
- Status last verified
- Mar 2016
- First submitted
- 7 Apr 2015
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02416414
- Acronym / sponsor ID
- CST007_10
- Conditions
- Cell-mediated Immune Response
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decided not to go forward with study for FDA submission.
- Enrolment
- 166 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Apr 2015 (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.
To compare the performance of the QuantiFERON Monitor assay against existing methodology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solid Organ Transplant Recipients | – | Device: QuantiFERON Monitor Assay, Device: Existing methodologySubjects who have received a Solid Organ Transplant. |
| Healthy Controls | – | Device: QuantiFERON Monitor Assay, Device: Existing methodologyHealthy individuals. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects who have either received a solid organ transplant or who are healthy.
Key inclusion criteria (3 listed)
- Provide Informed Consent
- Received a solid organ transplant
- Provide Informed Consent
Key exclusion criteria (8 listed)
- Pregnancy or recent lactation (<1yr)
- Treatment of Rejection
- Healthy Control
- Currently taking any immunomodulatory medication
- A history of immunosuppressive disease or immunosuppression condition or history of autoimmune diseases
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 |
|---|---|---|
| QuantiFERON Monitor AssayAssay to measure cell-mediated immune function using QuantiFERON Monitor assay. | Device | Healthy Controls, Solid Organ Transplant Recipients |
| Existing methodologyAssay to measure cell-mediated immune function using existing methodology. | Device | Healthy Controls, Solid Organ Transplant Recipients |
Primary outcome
Cell-mediated immune response.
Time frame: 1 day (At time of enrollment)
Results and safety
The study was stopped early (reason given: Sponsor decided not to go forward with study for FDA submission.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
Camille N Kotton, M.D. principal investigator
Transplant and Immunocompromised Host Infectious Diseases
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cell-mediated Immune Response, run by QIAGEN Gaithersburg, Inc at 4 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 29 Mar 2016. 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. 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 was stopped early (reason given: Sponsor decided not to go forward with study for FDA submission.). Results are not available in the source record.
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?
Cell-mediated immune response. (time frame: 1 day (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 29 Mar 2016.