Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C
Acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. Acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated when compared to baseline. The only means of differentiating acute rejection from other liver pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it may be difficult to distinguish acute rejection from another disease process, such as injury caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver transplant recipient can be used to determine if the transplanted liver is being rejected by the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute rejection and informative of the severity of HCV recurrence could allow for modulation of immunosuppression therapy and treat the clinical condition without the need for invasive liver biopsies.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Development of Gene Expression Signatures for the Diagnosis of Liver Allograft Rejection and Recurrent Hepatitis C Disease (CTOT-07)|
- Expression levels of mRNA and miRNA in peripheral blood cells, serum, and tissue at the time of for cause and protocol biopsies, and the diagnostic effectiveness of identified patterns [ Time Frame: +/- 10 day window from time of clinically indicated biopsy ] [ Designated as safety issue: No ]This assay study will analyze expression levels of mRNA and miRNA from NINV and HCV liver biopsy, whole blood, and/or serum samples from the ITN030ST study obtained within a +/- 10-day window of the biopsy.
Biospecimen Retention: Samples With DNA
Liver tissue, whole blood, and serum specimens
|Study Start Date:||August 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Patients enrolled in ITN030ST transplanted for liver failure resulting from non-viral, non-immune causes
Hepatitis C Virus (HCV) positive
Patients enrolled in ITN030ST transplanted for liver failure resulting from HCV genotype 1 infection
|Principal Investigator:||Abraham Shaked, MD, PhD||University of Pennsylvania|
|Study Chair:||Manikkam Suthanthiran, MD||Cornell University|