Novel Biomarkers of LivEr FibrosiS Study

Research Summary

Liver biopsy has long been the main method of assessing degrees of liver fibrosis which is then used to plantreatment or assess prognosis. In recent years the use of non-invasive markers of fibrosis has evolved.Several biomarker panels exist but recently several more have become available. Soluble VAP-1 (Vascular adhesionprotein) has been found to be elevated in patients with liver fibrosis as has CK-18 (Cytokeratin -18) fragments. Serumleptin has been found to be elevated in patients with cirrhosis but its relationship to severity of fibrosis is yet to beestablished in humans. Interferon gamma-induced protein 10 kDa Interleukin-1B and Monocyte Chemotactic Protein-1have all shown promise as markers in varying liver aetiologies.No published study has yet assessed these potential biomarkers in conjunction with liver biopsy and Fibroscan tocurrent non-invasive markers. Fibroscan is an ultrasound assessment of liver stiffness that helps quantify liver fibrosis.We intend to perform a prospective observational study to correlate these biomarkers with current measures of liverinjury and fibrosis aiming to assess the clinical benefit in monitoring patients with evolving liver injury.Eligible patients will have to be attending for an elective liver biopsy in keeping with standard NHS patient care.Patients will be seen in the Queen Elizabeth Hospital Birmingham (or other site) NHS pre-admission clinic and haveblood tests taken and a Fibroscan performed. These will be repeated at 12 months. These patients are usuallyfollowed up at 6 monthly intervals which the study protocol visits should ideally coincide with.No patient will have to undergo additional treatment outside that of their standard routine NHS care as a result of theirparticipation in the study.No clinical decisions will be made on the basis of the biomarker levels during the study.The study is funded by an NIHR grant.

Research Overview
PI Name Adams - DH
Sponsor University of Birmingham
Project Status Open
Proposed End Date 01/07/2013
Study Run through CRF? Yes
Target number of patients agreed to recruit 100
Recruitment so far 0