Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients (PROGENI-LI)

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: Liver Transplantation; Liver Transplant Recipients

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01672164

DAIT CTOT-14

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

202 participants in 1 patient group

Liver Transplant Recipients