Immunity, Cellular Clinical Trial
— QTF-MonitorOfficial title:
Clinical Evaluation of Quantiferon-Monitor to Predict Outcomes in Solid Organ Transplant Recipients
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 |
Verified date | June 2018 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network, Toronto General Hospital, Multi-Organ Transplant | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Deepali Kumar |
Canada,
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 |
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