Background: Our pilot study has shown that serum glycomic fingerprinting is a potential tool for noninvasive diagnosis of liver fibrosis for patients with chronic hepatitis B virus infection (CHB).In this study, we attempted to verify this approach by increasing the sample size and further investigate its application value in the post-treatment patients.Methods: Serum samples were collected from 149 treatment-naïve CHB patients who underwent liver biopsy as per protocol procedure for clinical trials.122 of them had serum samples collected after treatment with peginterferon and/or lamivudin.The patients were randomly divided into i) a biomarker discovery group for finding differential serum N-glycans and constructing N-glycome fingerprinting-based diagnostic model, and ii) an independent validation group for assessing the diagnostic performance.Results: When considering only treatment naïve samples, an optimized glycomic fingerprint composed of two glycans gave ROC curve areas of 0.84 (79% sensitivity, 84% specificity) and 0.89 (100% sensitivity, 79% specificity) for detecting significant liver fibrosis (Ishak score 2) and liver cirrhosis (Ishak score 4), respectively.When considering both treatment naïve and post-treatment samples, an optimized fingerprinting composed of two other glycans gave ROC curve areas of 0.77 (67% sensitivity, 70% specificity) and 0.87 (81% sensitivity, 87% specificity) for detecting significant liver fibrosis and liver cirrhosis, respectively.Conclusion: Serum N-glycome fingerprinting is a promising tool to supplement liver biopsy for assessing liver fibrosis in CHB patients before and after anti-viral treatment.

G. Abelev, Moscow V. Barak, Jerusalem R. Begent, London H. Biran, Tel Aviv E. Bombardieri, Milan O.P. Børmer, Oslo R.R. Brentani, São Paulo K. Chester, London E.P. Diamandis, Toronto A. Epenetos, London H.A. Fritsche, Houston, Tex. A. Fuks, Montreal P. Gold, Montreal S. Hammarström, Umeå F. Itoh, Kanagawa J.M. Jessup, Washington, D.C. H. Kato, Ube Y.S. Kim, San Francisco, Calif. M. Kuroki, Fukuoka J.P. Mach, Epalinges s./Lausanne R. Molina, Barcelona B. Pedley, London M.F. Rajewsky, Essen J. Schlom, Bethesda, Md. J.E. Shively, Duarte, Calif. U.-H. Stenman, Helsinki M. Toyota, Sapporo J. Uriel, Paris C. Wittekind, Leipzig H. zur Hausen, Heidelberg Tumor Markers, Tumor Targeting and Translational Cancer Research