This study is in progress, not accepting new patients

Molecular Assessment and Profiling of Liver Transplant Recipients

a study on Liver Transplant Biomarkers

Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Keywords

Liver Transplantation, Biomarkers, LiverCare

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego
    San Diego California 92037 United States
  • Keck Medical Center of USC
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CareDx
ID
NCT04793360
Study Type
Observational
Participants
Expecting 1500 study participants
Last Updated