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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2016

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Number of participants that develop Acute cellular rejection
    • Time Frame: 1 year
    • The results of the assay will be used to predict whether patients develop acute cellular rejection.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult SOT recipients on at least one immunosuppressive medication able to comply with the protocol. Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deepali Kumar
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Deepali Kumar, Physician, Transplant Infectious Diseases – University Health Network, Toronto

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