Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients

Completed

• Conditions: Liver Transplantation; Liver Transplant Recipients

• Registration Number: NCT01672164
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Rejection	24 months after liver transplant

Secondary Outcome Measures

Name	Time	Method
microRNA Profiling Plasma & Cells	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)
Recurrent Hepatitis-C Virus (HCV-R)	Baseline (Visit 1) to Month 24 (Visit 12)	Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R
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)	Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD
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)
Severity of acute rejection	Baseline (Visit 1) to Month 24 (Visit 12):	Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR
Incidence of death, graft loss, and need for liver retransplantation	Baseline (Visit 1) to Month 24 (Visit 12)

Trial Locations

Locations (6)

Northwestern University, Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States