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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02560857
Other study ID # 14-8133
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date May 2018

Study information

Verified date June 2018
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The investigators will use the results of the assay to predict whether patients develop opportunistic infections and predict organ rejection.


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 information / eligibility

Status Completed
Enrollment 151
Est. completion date May 2018
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada University Health Network, Toronto General Hospital, Multi-Organ Transplant Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Deepali Kumar

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
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