A statistical model predicting high hepatocyte proliferation index and the risk of developing hepatocellular carcinoma in patients with hepatitis C virus-related cirrhosis F. AZZAROLI*, A. COLECCHI*, F. LODATO*, D. TRERE `  , M. L. BACCHI REGGIANI à , D. FESTI*, G. M. PRATI*, E. ACCOGLI*, S. CASANOVA*, M. DERENZINI  , E. RODA* & G. MAZZELLA* *Department of Internal Medicine and Gastroenterology;  Department of Experimental Pathology; àInstitute of Cardiovascular Diseases, University of Bologna, Bologna, Italy Correspondence to: Dr F. Azzaroli, Dipartimento di Medicina Interna e Gastroenterologia, Ospedale S Orsola, Via Massarenti, 9, 40138 Bologna, Italy. E-mail: azzaroli@med.unibo.it Publication data Submitted 27 January 2006 First decision 21 February 2006 Resubmitted 11 March 2006 Accepted 25 March 2006 SUMMARY Background Incidence of hepatocellular carcinoma in hepatitis C virus-related cirrhosis is 4% per year. Although cost-effective, current screening could be improved. Aim To develop a statistical model including non-invasive parameters able to iden- tify patients at high risk of developing hepatocellular carcinoma. Methods One hundred and fifty-eight patients (73F:85M) with compensated chronic hepatitis C virus liver disease underwent evaluation, including argyrophilic nu- cleolar organizer regions proliferation index, and were followed up for 56.18  1.44 months. Results Fifty-six patients had chronic hepatitis without cirrhosis and low argyrophilic nucleolar organizer regions proliferation index (£25%), 65 had hepatitis C virus- related cirrhosis and low argyrophilic nucleolar organizer regions proliferation index and 37 had hepatitis C virus-related cirrhosis and high argyrophilic nu- cleolar organizer regions proliferation index (>25%). Groups were similar for gender and viral genotype distribution. None of the patients with chronic hepati- tis without cirrhosis developed hepatocellular carcinoma, compared with 6.1% of low argyrophilic nucleolar organizer regions proliferation index and 30.6% of high argyrophilic nucleolar organizer regions proliferation index (P ¼ 0.002). By multivariable logistic regression analysis, the following parameters were inde- pendently associated with hepatocellular carcinoma development and used for the development of the statistical model: platelets (OR 0.98), c-globulins (OR 0.111), alanine aminotransferase/aspartate aminotransferase ratio (OR 0.07), serum ferritin (OR 1.0) and ultrasonographyc pattern (coarse OR 2.9, coarse nod- ular OR 10.12). The statistical model properly allocated 95.9% of patients with low argyrophilic nucleolar organizer regions proliferation index and 72.2% of patients with high argyrophilic nucleolar organizer regions proliferation index. Conclusions The model, to be validated in large prospective studies, may help tailoring screening according to the risk of hepatocellular carcinoma development. Aliment Pharmacol Ther 24, 129–136 Alimentary Pharmacology & Therapeutics ª 2006 The Authors 129 Journal compilation ª 2006 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2006.02955.x