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

Immunity, Cellular Clinical Trial

— QTF-Monitor  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560857
• Other study ID #: 14-8133
• Status: Completed
• 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
• 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:

Related Conditions & MeSH terms

• Immunity, Cellular

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