Molecular Assessment and Profiling of Liver Transplant Recipients (NCT04793360) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Molecular Assessment and Profiling of Liver Transplant Recipients
United States1,500 participantsStarted 2021-05-26
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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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.
What they're measuring
1
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)
Timeframe: 2 years of accrual and 3 years follow up