Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics

National Institute of Allergy and Infectious Diseases (NIAID)6 sites in 1 country202 target enrollmentAugust 2012

ConditionsLiver Transplant Recipients Liver Transplantation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Liver Transplant Recipients
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment: 202
Locations: 6
Primary Endpoint: Acute Rejection
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

December 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects undergoing primary deceased-donor or living donor liver transplantation;
•Subject must be able to understand and provide informed consent.

Exclusion Criteria

•Need for combined organ transplantation;
•Previous solid organ and/or islet cell transplantation;
•Infection with HIV;
•Allergy to iodine;
•Inability or unwillingness of a participant to comply with study protocol;
•Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

Outcomes

Primary Outcomes

Acute Rejection

Time Frame: 24 months after liver transplant

Secondary Outcomes

Recurrent Hepatitis-C Virus (HCV-R)(Baseline (Visit 1) to Month 24 (Visit 12))
Protein expression profiles of plasma ( AR, HCV-R, CKD)(Baseline (Visit 1) to Month 24 (Visit 12))
Multiparameter Flow Cytometry - Viral Pathogens(Baseline (Visit 1) to Month 24 (Visit 12))
Chronic Kidney Disease(CKD)(Baseline (Visit 1) to Month 24 (Visit 12))
mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)(Baseline (Visit 1) to Month 24 (Visit 12))
mRNA expression profiles of liver biopsies (AR, HCV-R)(Baseline (Visit 1) to Month 24 (Visit 12))
Protein expression profiles of urine (CKD)(Baseline (Visit 1) to Month 24 (visit 12))
microRNA Profiling Plasma & Cells(Baseline (Visit 1) to Month 24 (Visit 12))
Severity of acute rejection(Baseline (Visit 1) to Month 24 (Visit 12):)
Incidence of death, graft loss, and need for liver retransplantation(Baseline (Visit 1) to Month 24 (Visit 12))
Incidence of opportunistic infections, malignancy, and cardiovascular complications(Baseline (Visit 1) to Month 24 (Visit 12))
Viral Monitoring - EBV & CMV(Baseline (Visit 1) to Month 24 (Visit 12))