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

NCT ID: NCT02560857

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 151 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-05-31

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.

Conditions

Immunity, Cellular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deepali Kumar

OTHER

Sponsor Role: lead

Responsible Party

Deepali Kumar

Physician, Transplant Infectious Diseases

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

14-8133

Identifier Type: -

Identifier Source: org_study_id