QuantiFERON-Monitor: A novel biomarker of immune function following lung transplantation

Does individual QuantiFERON-Monitor test results correlate to clinical outcomes including allograft rejection, infection and CMV reactivation in lung transplant recipients.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000747527

Enrollment

Registered

2015-07-20

Start date

2015-10-15

Completion date

2017-07-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

After lung transplantation patients are prescribed drugs, called immunosuppression medication, to control the immune system to stop them from rejecting the new lung(s). Managing immunosuppression medication is lifelong post-transplant, and the Lung Transplant Physicians take many factors into consideration when dosing medications. The purpose of this project is to determine if the blood tests, QuantiFERON-Monitor (QFM), which measures immunity and QuantiFERON-CMV (QFN-CMV), which measures immunity to a virus, could provide extra information for the Lung Transplant Physicians to help in their decisions about immunosuppression medications. The aim of this study is to observe if there is any relationship between both the QFM and QFN-CMV Test results and immunosuppression drug levels and doses, and any occurrence of rejection and infection after transplantation. This study will be observational, immunosupression drug managment will be managed by the Lung Transplant Physicians as per standard practice. The QFN-Monitor and QFN-CMV tests will be collected for comparsion at the end of the study, but will not alter patient care.

Interventions

This is a prospective observational study of a novel whole-blood immune function biomarker, the QuantiFERON-Monitor (QFM) and the QuantiFERON-CMV (QFN-CMV) test in the post lung transplantation population. The QFM test measures interferon-gamma production in plasma after stimulation to provide an overall marker of the recipients immune state. The QFN-CMV test measure interferon-gamma production directly related to CMV immunity to provide a marker of the recipients immune response to CMV. QFM & QFN-CMV will be measured pre-transplant, and then at five timepoints post transplant (2 & 6 weeks and 3, 6 & 12mths). Immune monitoring results will be correlated to clinical outcome at these timepoints, including bronchoscopic findings, lung function, infection, rejection and current immunosupressive medication regime. Participants will be followed till 12months post lung transplant.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adult (greater than or equal to 18 years) Single or Bilateral Lung Transplant or Heart-Lung Transplant Recipient Provided informed Consent

Exclusion criteria

Repeat transplant recipients Unable to peform their 12 month follow-up at our site.

Outcome results