Clinical trial NCT01672164: Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients
Official title: Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant Recipients
Liver Transplantation
Keywords: proteogenomic biomarker panels
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation
First posted: 2012-08-24
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver Transplant Recipients

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.


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.

Primary outcomes:
measure: Acute Rejection
timeFrame: 3 months after liver transplant
measure: Acute Rejection
timeFrame: 12 months after liver transplant
measure: Acute Rejection
timeFrame: 24 months after liver transplant
Secondary outcomes:
measure: Severity of acute rejection
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12):
measure: Recurrent Hepatitis-C Virus (HCV-R)
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Chronic Kidney Disease(CKD)
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Incidence of death, graft loss, and need for liver retransplantation
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Incidence of opportunistic infections, malignancy, and cardiovascular complications
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: mRNA expression profiles of liver biopsies (AR, HCV-R)
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Protein expression profiles of plasma ( AR, HCV-R, CKD)
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Protein expression profiles of urine (CKD)
timeFrame: Baseline (Visit 1) to Month 24 (visit 12)
measure: microRNA Profiling Plasma & Cells
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Multiparameter Flow Cytometry - Viral Pathogens
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Viral Monitoring - EBV & CMV
timeFrame: Baseline (Visit 1) to Month 24 (Visit 12)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Josh Levitsky, MD, MS
role: STUDY_CHAIR
affiliation: Northwestern University Feinberg School of Medicine
name: Michael Abecassis, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: