Molecular Assessment and Profiling of Liver Transplant Recipients

Study Overview
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Brief Summary
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The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.

Official Title
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Molecular Assessment and Profiling of Liver Transplant Recipients

Conditions
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Liver Transplantation, Biomarkers

Intervention / Treatment
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* Device: LiverCare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver transplant recipients <60 days post-transplant (de-novo or re-transplant). Participant is willing and able to give informed consent for participation in the trial. Male or Female, aged 12 years or above (Gillick Competent). In the Investigator's opinion, is able and willing to comply with all trial requirements. Exclusion Criteria: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI). Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. Participants who have participated in another research trial involving an investigational product in the past 12 weeks*. Multi-organ transplant recipients or dual organ transplant recipients. Patients with significant needle phobia.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LiverCare Surveillance<br>Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study | Device: LiverCare<br>* The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the results of LiverCare with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA) | LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance' | 2 years of accrual and 3 years follow up |