Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE)

CareDx

Status

Active, not recruiting

Conditions

Liver Transplantation

Biomarkers

Treatments

Device: LiverCare

Study type

Observational

Funder types

Industry

Identifiers

NCT04793360

SN-C-00015

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.