Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients
- Conditions
- Immunity, Cellular
- Registration Number
- NCT02560857
- Lead Sponsor
- Deepali Kumar
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants that develop Opportunistic infections 1 year The results of the assay will be used to predict whether patients develop opportunistic infections.
- Secondary Outcome Measures
Name Time Method Number of participants that develop Acute cellular rejection 1 year The results of the assay will be used to predict whether patients develop acute cellular rejection.
Trial Locations
- Locations (1)
University Health Network, Toronto General Hospital, Multi-Organ Transplant
🇨🇦Toronto, Ontario, Canada