Molecular Assessment and Profiling of Liver Transplant Recipients
NCT ID: NCT04793360
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1500 participants
OBSERVATIONAL
2021-05-26
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LiverCare Surveillance
Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study
LiverCare
The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.
Interventions
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LiverCare
The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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CareDx
INDUSTRY
Responsible Party
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Principal Investigators
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Kanish Mohib, PhD
Role: STUDY_DIRECTOR
CareDx
Locations
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Keck Medical Center of USC
Los Angeles, California, United States
MedStar Georgetown University Hospital
Washington D.C., 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
St 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
Baylor College of Medicine
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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SN-C-00015
Identifier Type: -
Identifier Source: org_study_id
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