Molecular Assessment and Profiling of Liver Transplant Recipients
- Conditions
- Liver TransplantationBiomarkers
- Interventions
- Device: LiverCare
- Registration Number
- NCT04793360
- Lead Sponsor
- CareDx
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LiverCare Surveillance LiverCare Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study
- Primary Outcome Measures
Name Time Method 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) 2 years of accrual and 3 years follow up LiverCare will be measured 7 times in year 1 and quarterly each year. A total of 15 surveillance points per subject in addition to for-cause testing based on clinical changes. Liver care will be collected at the time of all histologic analyses whether 'for cause' or 'surveillance'
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Washington Unversity in St. Louis
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center/ Nebraska Medicine
🇺🇸Omaha, Nebraska, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical Unversity of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Tennessee_Methodist Healthcare
🇺🇸Memphis, Tennessee, United States
Methodist Health System
🇺🇸Dallas, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States