Molecular Assessment and Profiling of Liver Transplant Recipients

Launched by CAREDX · Mar 9, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how to better monitor and assess the health of people who have received liver transplants. The study aims to compare a new method called LiverCare, which uses advanced testing techniques, with the usual monitoring practices like blood tests and biopsies. The goal is to see how well these methods can predict and identify issues such as organ rejection or disease recurrence, as well as to improve overall patient care after a liver transplant.

To be eligible for this trial, participants need to be liver transplant recipients who are less than 60 days post-surgery and are aged 12 or older. They should also be able to give their consent to participate. During the study, participants will undergo various tests to track their liver health and other important markers. It’s important to note that individuals who are pregnant, those with significant liver issues, or anyone needing major surgery soon will not be able to participate. Overall, this study hopes to enhance the monitoring process for liver transplant patients, leading to better outcomes and care.

Gender

ALL

Eligibility criteria

• 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.