Table 1.
Clinical characteristics of the subjects in each cohort
| Characteristics | Cohort A | Cohort B | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Train Set | P Value | Test Set | P Value | Independent Validation Set | P Value | ||||
| (n = 210) | (n = 90) | (n = 318) | |||||||
| Controls | Cases | Controls | Cases | Controls | Cases | ||||
| n | 140 | 70 | 60 | 30 | 134 | 184 | |||
| Age (years) [range] | 53.7 ± 10.0 [28.0‐75.0] | 56.9 ± 9.3 [24.0‐78.0] | 0.0262 | 51.2 ± 8.1 [28.0‐65.0] | 59.7 ± 8.8 [46.0‐74.0] | <0.001 | 50.8 ± 1.7 [24.0‐80.0] | 57.9 ± 9.4 [35.0‐79.0] | <0.001 |
| Sex, n (%) | 0.5926 | 1.0000 | 0.2115 | ||||||
| Male | 108 (77.1%) | 57 (81.4%) | 47 (78.3%) | 23 (76.7%) | 99 (73.9%) | 148 (80.4%) | |||
| Female | 32 (22.9%) | 13 (19.6%) | 13 (21.7%) | 7 (23.3%) | 35 (26.1%) | 36 (19.6%) | |||
| AFP (ng/mL), median [IQR] | 2.6 [1.9‐4.1] | 6.7 [2.8‐32.3] | <0.001 | 2.35 [1.9‐3.3] | 15.85 [4.0‐909.9] | <0.001 | 2.8 [1.8‐3.9] | 8.3 [3.4‐6.1] | <0.001 |
| DCP (mAU/mL), median [IQR] | 15.0 [13.0‐18.5] | 40.0 [24.3‐121.3] | <0.001 | 16.0 [14.0‐18.5] | 36.0 [23.8‐131.9] | <0.001 | 19.5 [15.0‐23.8] | 71.5 [27.8‐268.3] | <0.001 |
| AST (U/L) | 34.5 | 30.5 | 0.2189 | 32.9 | 30.7 | 0.4686 | 44.0 | 156.6 | <0.001 |
| ALT (U/L) | 33.0 | 30.1 | 0.7168 | 36.3 | 27.6 | 0.5403 | 46.8 | 143.8 | <0.001 |
| Prothrombin time (INR) | 1.1 ± 0.1 | 1.0 ± 0.2 | 0.5661 | 1.1 ± 0.2 | 1.0 ± 0.1 | 0.7840 | 1.3 ± 1.9 | 1.2 ± 0.1 | <0.001 |
| Albumin (g/dL) | 4.2 ± 0.4 | 3.9 ± 0.3 | <0.001 | 4.3 ± 0.4 | 3.9 ± 0.4 | <0.001 | 4.5 ± 0.4 | 3.7 ± 0.5 | <0.001 |
| Bilirubin (mg/dL) | 1.2 ± 0.6 | 0.7 ± 0.4 | <0.001 | 1.2 ± 0.9 | 0.6 ± 0.4 | <0.001 | 0.9 ± 0.7 | 1.3 ± 0.6 | <0.001 |
| Creatinine (mg/dL) | 0.8 ± 0.2 | 0.8 ± 0.2 | 0.3185 | 0.9 ± 0.2 | 0.9 ± 0.2 | 0.1606 | 1.0 ± 1.1 | 0.9 ± 0.2 | 0.3119 |
| Etiology, n (%) | 0.8571 | <0.001 | <0.001 | ||||||
| HBV | 96 (68.6%) | 52 (74.3%) | 51 (85.0%) | 20 (66.7%) | 117 (87.3%) | 140 (76.1%) | |||
| HCV | 10 (7.1%) | 4 (5.7%) | 1 (1.7%) | 2 (6.7%) | 15 (11.2%) | 8 (4.3%) | |||
| HBV and HCV | 3 (2.1%) | 1 (1.4%) | 2 (3.3%) | 0 | 0 | 1 (0.5%) | |||
| Others | 31 (22.1%) | 13 (18.6%) | 6 (10.0%) | 8 (26.7%) | 2 (1.5%) | 35 (19.0%) | |||
| Child‐Pugh score, n (%) | 0.0290 | <0.001 | <0.001 | ||||||
| 5 | 121 (86.4%) | 58 (82.9%) | 54 (90.0%) | 22 (73.3%) | 127 (94.8%) | 100 (54.3%) | |||
| 6 | 10 (7.1%) | 12 (17.1%) | 2 (3.3%) | 8 (26.7%) | 6 (4.5%) | 60 (32.6%) | |||
| 7 | 5 (3.6%) | 0 | 3 (5.0%) | 0 | 0 | 22 (12.0%) | |||
| 8 | 4 (2.9%) | 0 | 1 (1.7%) | 0 | 0 | 1 (0.5%) | |||
| 9 | 0 | 0 | 0 | 0 | 1 (0.7%) | 1 (0.5%) | |||
| Child‐Pugh class, n (%) | 0.0476 | 0.3659 | <0.001 | ||||||
| 0 | 1 (0.7%) | 2 (2.9%) | 0 | 0 | 0 | 0 | |||
| A | 130 (92.9%) | 68 (97.1%) | 56 (93.3%) | 30 (100%) | 133 (99.3%) | 160 (87.0%) | |||
| B | 9 (6.4%) | 0 | 4 (6.7%) | 0 | 1 (0.7%) | 24 (13.0%) | |||
| Tumor size (cm) | ‐ | 2.6 ± 1.3 | ‐ | 2.8 ± 1.7 | ‐ | 3.4 ± 2.4 | |||
| Tumor number, n (%) | |||||||||
| 1 | ‐ | 67 (95.7%) | ‐ | 28 (93.3%) | ‐ | 172 (93.5%) | |||
| 2 | ‐ | 2 (2.9%) | ‐ | 2 (6.7%) | ‐ | 12 (6.5%) | |||
| ≥3 | ‐ | 1 (1.4%) | ‐ | 0 | ‐ | 0 | |||
| BCLC stage, n (%) | |||||||||
| 0 | ‐ | 27 (38.6%) | ‐ | 11 (36.7%) | ‐ | 36 (19.6%) | |||
| A | ‐ | 37 (52.9%) | ‐ | 16 (53.3%) | ‐ | 123 (66.8%) | |||
| B | ‐ | 6 (8.6%) | ‐ | 3 (10%) | ‐ | 25 (13.6%) | |||
Except where indicated, data are presented as mean ± SD or median [IQR] (for AFP and DCP). P values for sex, etiology, Child‐Pugh score, Child‐Pugh class were calculated by the chi‐squared test. P values for others were calculated by the t test. Reference ranges for each liver function test are based on laboratory reference values from Massachusetts General Hospital as follows( 43 ): AST, 0‐35 U/L; ALT, 0‐35 U/L; albumin, 3.5‐5.5 g/dL; bilirubin, 0.3‐1.0 mg/dL; creatinine, <1.5 mg/dL; prothrombin time, 11.1‐13.1 seconds. The reference range for prothrombin time as INR is <1.1, per the Mayo Clinic (www.mayoclinic.org).
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; INR, international normalized ratio; IQR, interquartile range.