Parameters | Development cohort1 | Validation cohort | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Hepatitis | Cirrhosis | Benign SOL | HC | HCC | Hepatitis | Cirrhosis | Benign SOL | HCC | ||
(n = 289) | (n = 314) | (n = 179) | (n = 508) | (n = 908) | (n = 451) | (n = 308) | (n = 96) | (n = 157) | ||
Age, mean (SD), years | 50.2 (13.3) | 45.1 (13.6) | 52.2 (13.1) | 41.2 (11.9) | 53.5 (10.1) | 50.7 (9.4) | 58.1 (10.7) | 58.5 (12.4) | 59.6 (120) | |
Sex, n (%) | ||||||||||
 Male | 195 (67.5%) | 213 (67.8%) | 101 (56.4%) | 252 (49.6%) | 752 (82.8%) | 345 (76.5%) | 206 (66.9%) | 58 (60.4%) | 133 (84.7%) | |
 Female | 94 (32.5%) | 101 (32.2%) | 78 (43.6%) | 256 (50.4%) | 156 (17.2%) | 106 (23.5%) | 102 (33.1%) | 38 (39.6%) | 24 (15.3%) | |
Etiology, n (%) | ||||||||||
 HBV | 289 (100%) | 289 (100%) | / | 0 (0%) | 289 (100%) | 430 (95.3) | 194 (63.0) | 36 (37.5) | 122 (77.7) | |
 HCV | 0 (0%) | 0 (0%) | / | 0 (0%) | 0 (0%) | 4 (0.9) | 27 (8.8) | 6 (6.3) | 10 (6.4) | |
 Alcoholic | 0 (0%) | 0 (0%) | / | 0 (0%) | 0 (0%) | 3 (0.7) | 33 (10.7) | 5 (5.2) | 7 (4.4) | |
 Others (Schistosomiasis, HBV & HCV overlapping infection, HEV) | 0 (0%) | 0 (0%) | / | 0 (0%) | 0 (0%) | 14 (3.1) | 54 (17.5) | 49 (51.0) | 18 (11.5) | |
 BCLC stage, 0+A/B+C/D, n (%) |  |  |  |  | 318 (35.0)/590 (65.0)/0 (0) |  |  |  | 32 (20.4)/99 (63.0)/26 (16.6) | |
Child-Pugh class, n (%) | ||||||||||
 A | 289 (100) | 312 (99.4) | 175 (97.8%) | 508 (100%) | 903 (99.4) | 414 (91.8) | 192 (62.3) | 71 (74) | 68 (43.3) | |
 B | 0 | 2 (0.6) | 4 (2.2%) | 0 | 4 (0.4) | 29 (6.4) | 95 (30.9) | 23 (24) | 53 (33.8) | |
 C | 0 | 0 | 0 | 0 | 1 (0.2) | 8 (1.8) | 21 (6.8) | 2 (2.0) | 36 (22.9) | |
 Total bilirubin, mean (SD), μmol/L | 15.1 (12.2) | 56.6 (88.4) | 18.0 (21.3) | 16.2 (9.2) | 16.9 (36.1) | 27.6 (75.6) | 47.7 (43.2) | 32.3 (59.7) | 79.9 (133.6) | |
 Platelet, mean (SD), 109/L | 193.7 (69.8) | 117.4 (71.4) | 226.6 (104.3) | 189.2 (46.5) | 169.8 (77.7) | 168.1 (59.8) | 105.6 (70.0) | 150.5 (72.3) | 147.6 (85.4) | |
 Alanine aminotransferase, mean (SD), U/L | 35.8 (45.7) | 122.9 (268.1) | 42.2 (64.5) | 34.7 (34.6) | 43.4 (56.4) | 80.1 (359.9) | 47.4 (126.7) | 73.0 (177.8) | 89.8 (273.6) | |
 Aspartate aminotransferase, mean (SD), U/L | / | / | / | / | / | 60.3 (197.5) | 53.6 (88.3) | 64.9 (145.2) | 134.3 (178.0) | |
 Gamma-glutamyltransferase, mean (SD), U/L | / | / | / | / | / | 48.6 (90.0) | 77.9 (122.5) | 78.1 (110.9) | 211.2 (217.7) | |
 Gamma-glutamyltransferase/aspartate aminotransferase ratio, mean (SD) | / | / | / | / | / | 1.31 (1.91) | 1.70 (2.05) | 1.64 (1.52) | 2.35 (2.49) | |
 Prothrombin time, mean (SD), s | 11.5 (0.9) | 14.5 (3.5) | 11.4 (1.4) | 11.5 (0.7) | 11.9 (1.1) | 13.7 (7.7) | 14.6 (4.8) | 12.8 (3.0) | 14.5 (5.5) | |
 International normalized ratio, mean (SD) | 0.96 (0.07) | 1.24 (0.31) | 0.95 (0.09) | 0.97 (0.04) | 1.03 (0.45) | 1.26 (0.68) | 1.34 (0.44) | 1.19 (0.28) | 1.34 (0.49) | |
 Albumin, mean (SD), g/L | 42.0 (3.7) | 38.5 (5.7) | 42.6 (4.1) | 42.8 (4.7) | 42.2 (4.7) | 43.0 (5.4) | 35.5 (7.2) | 38.2 (6.1) | 32.6 (6.4) | |
 Diabetes mellitus, n (%) | 4 (1.4) | 8 (2.5) | 8 (4.5) | 0 (0) | 71 (7.8) | 1 (0.2) | 21 (6.8) | 2 (2.1) | 17 (10.8) | |
 AFP, mean (SD), log ng/mL | / | / | / | / | / | 1.46 (1.09) | 1.70 (1.32) | 1.87 (1.55) | 5.94 (3.85) | |
 PIVKA-II, mean (SD), log mAU/mL | / | / | / | / | / | 3.14 (0.58) | 3.33 (1.00) | 3.54 (1.08) | 8.47 (2.56) | |
 HBeAg-negative, (%, n) | / | / | / | / | / | (74.6, 406) | (86.6, 186) | (82.9, 35) | (84.2, 114) | |
 HBV DNA, < 50 IU/ml, (%, n) | / | / | / | / | / | (56.8, 382) | (74.5, 188) | (56.3, 32) | (20.2, 119) |