Immunity, CellularQTF-MonitorNCT02560857
Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients
An observational study of Immunity, Cellular, run by Deepali Kumar at 1 site in Canada.
Trial summary
The study will prospectively determine the clinical utility of non-pathogen specific cellular immunity assessment using the Quantiferon-Monitor to quantify the degree of immunosuppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunity, Cellular
- What is being tested?
- Quantiferon-Monitor assay
- How many people
- 151 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult SOT recipients on at least one immunosuppressive medication.
Who may be able to join
- Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, M5G2N2
About this study
The study will prospectively determine the clinical utility of non-pathogen specific cellular immunity assessment using the Quantiferon-Monitor to quantify the degree of immunosuppression. The investigators will use the results of the assay to predict whether patients develop opportunistic infections and predict organ rejection.
Read the detailed description
Solid organ transplant (SOT) recipients undergo life-long immunosuppression to prevent allograft rejection. However, this also puts patients at significant risk for opportunistic infection. The degree of immunosuppression varies for each individual and is likely influenced by a combination of clinical factors such as antirejection medication, comorbidities, patient age as well as the state of patient immune system. Thus far, there have been no standardized methods to quantify the degree of global immunosuppression. A new blood test (Quantiferon-Monitor) has been recently developed that might help predict the level of immune suppression. The purpose of this study is to determine whether this new test will help determine a person's level of immune suppression after organ transplant. This will be done by trying to relate the level of immunity with the development of infection or rejection. If the test for immunosuppression is helpful, it may help us to better take into account the differences in patients when designing therapy. Ultimately, it may help develop better ways for preventing infections and transplant rejections.
- Conditions
- Immunity, Cellular
- Being tested
- Quantiferon-Monitor assay
- Keywords
- Quantiferon-Monitor, organ rejection, global immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantiferon-Monitor assayOther
The QFT-Monitor assay is a recently developed non-pathogen specific immune assay based on immune activation of both innate and adaptive immunity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that develop Opportunistic infections
The results of the assay will be used to predict whether patients develop opportunistic infections.
Measured: 1 year
Secondary outcomes (1)
Number of participants that develop Acute cellular rejection
The results of the assay will be used to predict whether patients develop acute cellular rejection.
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 posted25 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunity, CellularStudies 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepali Kumar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deepali Kumar, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560857
- Sponsor's protocol ID
- 14-8133
- Acronym
- QTF-Monitor
- Status last verified
- Jun 2018
- First submitted
- 23 Sep 2015
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02560857
- Acronym / sponsor ID
- QTF-Monitor / 14-8133
- Conditions
- Immunity, Cellular
- Keywords
- Quantiferon-Monitor, organ rejection, global immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Deepali KumarUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 25 Sep 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.
The study will prospectively determine the clinical utility of non-pathogen specific cellular immunity assessment using the Quantiferon-Monitor to quantify the degree of immunosuppression. The investigators will use the results of the assay to predict whether patients develop opportunistic infections and predict organ rejection.
Detailed description
Solid organ transplant (SOT) recipients undergo life-long immunosuppression to prevent allograft rejection. However, this also puts patients at significant risk for opportunistic infection. The degree of immunosuppression varies for each individual and is likely influenced by a combination of clinical factors such as antirejection medication, comorbidities, patient age as well as the state of patient immune system. Thus far, there have been no standardized methods to quantify the degree of global immunosuppression. A new blood test (Quantiferon-Monitor) has been recently developed that might help predict the level of immune suppression. The purpose of this study is to determine whether this new test will help determine a person's level of immune suppression after organ transplant. This will be done by trying to relate the level of immunity with the development of infection or rejection. If the test for immunosuppression is helpful, it may help us to better take into account the differences in patients when designing therapy. Ultimately, it may help develop better ways for preventing infections and transplant rejections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult SOT recipients on at least one immunosuppressive medication.
Key inclusion criteria (1 listed)
- Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol.
Key exclusion criteria (1 listed)
- None
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 assayThe QFT-Monitor assay is a recently developed non-pathogen specific immune assay based on immune activation of both innate and adaptive immunity. | Other | – |
Primary outcome
Number of participants that develop Opportunistic infections
Time frame: 1 year
The results of the assay will be used to predict whether patients develop opportunistic infections.
1 secondary outcome
Number of participants that develop Acute cellular rejection
Time frame: 1 year
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 Jun 2018.
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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.
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 Immunity, Cellular, run by Deepali Kumar at 1 site in Canada.
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 1 inclusion and 1 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 Jun 2018. 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 Canada. 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?
Number of participants that develop Opportunistic infections (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 20 Jun 2018.