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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiverCare Surveillance | Participants undergoing orthotopic liver transplant (de-novo or re-transplant) will be considered for this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiverCare | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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' | 2 years of accrual and 3 years follow up |
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Inclusion Criteria:
Exclusion Criteria:
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All liver transplant patients without exclusion criteria will be eligible to enter the study. Patients will be approached by the study team at the time of transplant or within 60 days post-transplant to discuss the trial, consent and enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Kanish Mohib, PhD | CareDx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States | ||
| MedStar Georgetown University Hospital |
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| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington Unversity in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center/ Nebraska Medicine | Omaha | Nebraska | 68198 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Medical Unversity of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Tennessee_Methodist Healthcare | Memphis | Tennessee | 38104 | United States |
| Methodist Health System | Dallas | Texas | 75203 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |