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Clinical Trials/NCT01672164
NCT01672164CompletedNot Applicable

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 enrollmentStarted: August 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
202
Locations
6
Primary Endpoint
Acute Rejection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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))

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (6)

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Discovery and Validation of Proteogenomic... | Clinical Trial