Molecular Assessment and Profiling of Liver Transplant Recipients

NCT ID: NCT04793360

Last Updated: 2026-01-13

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2028-03-31

Brief Summary

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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

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Conditions

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Liver Transplantation Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CareDx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

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Piedmont Healthcare

Atlanta, Georgia, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

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Tulane University

New Orleans, Louisiana, United States

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Washington Unversity in St. Louis

St Louis, Missouri, United States

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University of Nebraska Medical Center/ Nebraska Medicine

Omaha, Nebraska, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Westchester Medical Center

Valhalla, New York, United States

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Atrium Health

Charlotte, North Carolina, United States

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Duke University

Durham, North Carolina, United States

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University of Cincinnati

Cincinnati, Ohio, United States

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INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

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Medical Unversity of South Carolina

Charleston, South Carolina, United States

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University of Tennessee_Methodist Healthcare

Memphis, Tennessee, United States

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Methodist Health System

Dallas, Texas, United States

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Baylor College of Medicine

Houston, Texas, United States

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Intermountain Medical Center

Murray, Utah, United States

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Virginia Commonwealth University

Richmond, Virginia, United States

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SN-C-00015

Identifier Type: -

Identifier Source: org_study_id

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