Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients

Liver Transplantation Clinical Trial

— PROGENI-LI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672164
• Other study ID #: DAIT CTOT-14
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: September 1, 2016
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Transplant Recipients
• Liver Transplantation

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Mount Sinai School of Medicine	New York	New York
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Rejection	The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.	3 months after liver transplant	Yes
Primary	Acute Rejection		12 months after liver transplant	Yes
Primary	Acute Rejection		24 months after liver transplant	Yes
Secondary	Severity of acute rejection	Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR	Baseline (Visit 1) to Month 24 (Visit 12):	Yes
Secondary	Recurrent Hepatitis-C Virus (HCV-R)	Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R	Baseline (Visit 1) to Month 24 (Visit 12)	Yes
Secondary	Chronic Kidney Disease(CKD)	Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD	Baseline (Visit 1) to Month 24 (Visit 12)	Yes
Secondary	Incidence of death, graft loss, and need for liver retransplantation		Baseline (Visit 1) to Month 24 (Visit 12)	Yes
Secondary	Incidence of opportunistic infections, malignancy, and cardiovascular complications		Baseline (Visit 1) to Month 24 (Visit 12)	Yes
Secondary	mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)		Baseline (Visit 1) to Month 24 (Visit 12)	No
Secondary	mRNA expression profiles of liver biopsies (AR, HCV-R)		Baseline (Visit 1) to Month 24 (Visit 12)	No
Secondary	Protein expression profiles of plasma ( AR, HCV-R, CKD)		Baseline (Visit 1) to Month 24 (Visit 12)	No
Secondary	Protein expression profiles of urine (CKD)		Baseline (Visit 1) to Month 24 (visit 12)	No
Secondary	microRNA Profiling Plasma & Cells		Baseline (Visit 1) to Month 24 (Visit 12)	No
Secondary	Multiparameter Flow Cytometry - Viral Pathogens		Baseline (Visit 1) to Month 24 (Visit 12)	No
Secondary	Viral Monitoring - EBV & CMV		Baseline (Visit 1) to Month 24 (Visit 12)	No

External Links

•   Clinical Trials in Organ Transplantation (CTOT)
•   National Institute of Allergy and Infectious Diseases (NIAID)