Status:
ACTIVE_NOT_RECRUITING
Molecular Assessment and Profiling of Liver Transplant Recipients
Lead Sponsor:
CareDx
Conditions:
Liver Transplantation
Biomarkers
Eligibility:
All Genders
12+ years
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 prima...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04793360
Start Date
May 26 2021
End Date
March 31 2028
Last Update
April 11 2025
Active Locations (26)
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1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
2
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
3
Tampa General Hospital
Tampa, Florida, United States, 33606
4
Piedmont Healthcare
Atlanta, Georgia, United States, 30309