Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients

Conditions
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Immunity, Cellular

Intervention / Treatment
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* Other: Quantiferon-Monitor assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quantiferon-Monitor assay|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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that develop Opportunistic infections | The results of the assay will be used to predict whether patients develop opportunistic infections. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that develop Acute cellular rejection | The results of the assay will be used to predict whether patients develop acute cellular rejection. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quantiferon-Monitor, organ rejection, global immunity