Table 3.
Biomarkers to assess graft injury after liver transplantation.
| Clinical trial title and identifier | Institution | Enrolment | Start date | End date | Description |
|---|---|---|---|---|---|
| Serum Markers of Ischemia-Reperfusion Injury in Liver Transplant Patients [NCT00698399] | Vanderbilt University Medical Center | 20 | Mar 2008 | Feb 2010 | Observational trial of markers (TMAO, NGAL, cystatin-C, and allantoin) in the serum of patients who are undergoing LT surgery. |
| Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C [NCT01428700] | University of Pennsylvania | 275 | Aug 2011 | Jan 2013 | Observational study evaluating whether certain patterns of biomarkers in blood post-LT can be used to determine if the transplanted liver is being rejected or sustaining injury. |
| Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance | Hospital Clinic of Barcelona | 25 | Sep 2011 | Jan 2013 | Non-randomised prospective study in which gradual weaning of immunosuppressive drugs will be offered to LT recipients exhibiting a favourable peripheral blood gene expression profile. |
| Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients [NCT01672164] | Northwestern University Feinberg School of Medicine | 202 | Aug 2012 | Dec 2015 | The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in LT patients. |
| The Relationship of Hepatobiliary microRNA Expression Profile and Clinical Outcome in Liver Transplantation [NCT02307890] | University of Edinburgh | 100 | Aug 2014 | Aug 2020 | Observational study correlating miRNA levels in bile duct biopsies taken during LT with the incidence of IC following LT. |
| Liver Immunosuppression Free Trial (LIFT) [NCT02498977] | King's College London | 148 | Oct 2015 | Oct 2021 | Prospective interventional study analysing the risk/benefit ratio of employing transcriptional biomarkers to guide immunosuppression withdrawal post-LT. |
| Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation [NCT03396016] | University Health Network, Toronto | 140 | Apr 2018 | Apr 2021 | Observational study validating the use of coagulation cofactor Factor V as a predictive biomarker of graft function after LT. |
| Enteric Microbiome and Liver Transplantation [NCT03666312 | IRCCS Ospedale San Raffaele | 275 | Sep 2018 | Aug 2021 | Observational study of the faecal microbiome of LT patients in combination with a large panel of clinical, lab and functional parameters correlated to different clinical outcomes. |
| Liquid Biopsy-based Monitoring System for Relapse of HCC After Liver Transplantation: A Multi-center and Prospective Study [NCT03708705] | Zhejiang University | 500 | Nov 2018 | Jul 2020 | Prospective study aiming to develop a liquid biopsy-based biomarker system for relapse of HCC tumour post-LT using genomic and proteomic information. |
| Monocytic Expression of HLA-DR After Liver Transplantation (EdMonHG) [NCT03995537] | Hospices Civils de Lyon | 100 | Feb 2020 | Sep 2023 | Observational study examining the expression of monocytic surface markers (HLA-DR) in blood and their association with post-LT immune dysfunction (acute cell rejection and sepsis). |
| Non-invasive Rapid Assessment of Patients with Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan. | Leiden University Medical Centre; King's College Hospital NHS Trust | 131 | Aug 2020 | Oct 2020 | Prospective biomarker trial comparing the accuracy of a new test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of LT recipients. |
| Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year. [NCT04621812] | The Institute of Liver and Biliary Sciences | 100 | Nov 2020 | Oct 2022 | Observational study analysing the role of gut microflora an early biomarker for graft dysfunction and its influence on immune remodelling for the prediction of post-LT infection or rejection. |
| Molecular Assessment and Profiling of Liver Transplant Recipients [NCT04793360] | Icahn School of Medicine at Mount Sinai | 1500 | May 2021 | Dec 2025 | Prospective observational study to assess the correlation between clinical events (e.g., rejection, recurrent disease, biliary obstruction), graft histology, dd-cfDNA levels, and gene expression profiling |
dd-cfDNA, deceased donor cell-free DNA; HCC, hepatocellular carcinoma; HLA, human leukocyte antigen; IC, ischaemic cholangiopathy; LT, liver transplantation; NGAL, neutrophil gelatinase-associated lipocalin; TMAO, trimethylamine N-oxide.