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Trial registered on ANZCTR


Registration number
ACTRN12615000747527
Ethics application status
Approved
Date submitted
18/06/2015
Date registered
20/07/2015
Date last updated
7/11/2018
Date data sharing statement initially provided
7/11/2018
Date results information initially provided
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
QuantiFERON-Monitor: A novel biomarker of immune function following lung transplantation
Scientific title
Does individual QuantiFERON-Monitor test results correlate to clinical outcomes including allograft rejection, infection and CMV reactivation in lung transplant recipients.
Secondary ID [1] 286940 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Transplantation 295364 0
Chronic Allograft Dysfunction 295365 0
Cytomegalovirus 295366 0
Condition category
Condition code
Respiratory 295632 295632 0 0
Other respiratory disorders / diseases
Infection 295633 295633 0 0
Other infectious diseases
Inflammatory and Immune System 295856 295856 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 292132 0
Not applicable
Comparator / control treatment
N/A - Observational Study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295353 0
Evaluation of immune monitoring with the QFN-Monitor assay in patients undergoing lung transplantation.
The QFN-Monitor test results will be observationally compared to patients clinical immune state, including routine IgG levels.
This outcome is to evaluate if a relationship is present between the clinical immune status of a lung transplant receipient and the QFN-Monitor results.
Timepoint [1] 295353 0
Assessment of immune state, including the QFM and QFN-CMV tests, will occur pre-transplant, and at 5 time points in the first 12 months post transplant. These being 2 and 6 weeks and 3, 6 , 12 months post transplant.
Secondary outcome [1] 315401 0
Evaluate the relationship between QFN-Monitor results and immunosuppressive drug levels and doses.
Observational assessment of this outcome will occur.
QFN-Monitor results will be collected, along with immunosuppressive drug levels, ie Tacrolimus Level or Everolimus Levels, (retrieved from Medical Records provided by a NATA approved Pathology Service) and drug doses (as documented in medical records) during the first 12mths post lung transplant and statistically evaluated for any relationship.
Timepoint [1] 315401 0
Assessment of immune state, including the QFM and QFN-CMV tests, will occur pre-transplant, and at 5 time points in the first 12 months post transplant. These being 2 and 6 weeks and 3, 6 , 12 months post transplant.
Secondary outcome [2] 315402 0
Evaluate the relationship between QFN-Monitor and QFN-CMV results and the incidence of allograft rejection.
Allograft rejection will be identifed through Biopsy results according to the ISHLT gradings, or as documented as clinically likely by a Lung Transplant Physician.
Timepoint [2] 315402 0
Assessment of immune state, including the QFM and QFN-CMV tests, will occur pre-transplant, and at 5 time points in the first 12 months post transplant. These being 2 and 6 weeks and 3, 6 , 12 months post transplant.
Secondary outcome [3] 315495 0
Evaluate the relationship between QFN-Monitor and QFN-CMV results and the incidence of clinical infection.
Clinical Infection will be identified through postive culture, viral results and clinically indicators, including hopsital admission.
Timepoint [3] 315495 0
Assessment of immune state, including the QFM and QFN-CMV tests, will occur pre-transplant, and at 5 time points in the first 12 months post transplant. These being 2 and 6 weeks and 3, 6 , 12 months post transplant.
Secondary outcome [4] 315496 0
Evaluate the relationship between QFN-Monitor and QFN-CMV results and the incidence of CMV reactivation.
CMV reactivation will be identified through positive CMV viral load in blood or BAL and clinically indicators such as cmv gastritis.
Timepoint [4] 315496 0
Assessment of immune state, including the QFM and QFN-CMV tests, will occur pre-transplant, and at 5 time points in the first 12 months post transplant. These being 2 and 6 weeks and 3, 6 , 12 months post transplant.

Eligibility
Key inclusion criteria
Adult (greater than or equal to 18 years)
Single or Bilateral Lung Transplant or Heart-Lung Transplant Recipient
Provided informed Consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Repeat transplant recipients
Unable to peform their 12 month follow-up at our site.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 6984 0
United States of America
State/province [1] 6984 0
Colorado

Funding & Sponsors
Funding source category [1] 291503 0
Commercial sector/Industry
Name [1] 291503 0
QIAGEN
Address [1] 291503 0
19300 Germantown Road
Germantown
Maryland
20874
Country [1] 291503 0
United States of America
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Road
Melbourne
Victoria
3004
Country
Australia
Secondary sponsor category [1] 290182 0
Hospital
Name [1] 290182 0
University Of Colorado Medical Centre
Address [1] 290182 0
University of Colorado Hospital
Mailstop F771
Aurora
CO 80045
Country [1] 290182 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293043 0
The Alfred Hospital Ethics Commitee
Ethics committee address [1] 293043 0
Dept of Ethics and Reserach
The Alfred Hospital
Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 293043 0
Australia
Date submitted for ethics approval [1] 293043 0
25/06/2015
Approval date [1] 293043 0
01/07/2015
Ethics approval number [1] 293043 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57810 0
A/Prof Glen Westall
Address 57810 0
The Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Country 57810 0
Australia
Phone 57810 0
+61 3 9076 2000
Fax 57810 0
Email 57810 0
g.westall@alfred.org.au
Contact person for public queries
Name 57811 0
A/Prof Glen Westall
Address 57811 0
The Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Country 57811 0
Australia
Phone 57811 0
+61 3 9076 2000
Fax 57811 0
Email 57811 0
g.westall@alfred.org.au
Contact person for scientific queries
Name 57812 0
A/Prof Glen Westall
Address 57812 0
The Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Country 57812 0
Australia
Phone 57812 0
+61 3 9076 2000
Fax 57812 0
Email 57812 0
g.westall@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD not approved for sharing under current Ethics Approval
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary