Biomarkers, Liver Transplantation
Conditions
Brief summary
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.
Interventions
DEVICELiverCare
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.
Sponsors
CareDx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 2 years of accrual and 3 years follow up | 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' |
Countries
United States
Contacts
STUDY_DIRECTORKanish Mohib, PhD
CareDx
Outcome results
None listed