Table 1. Participant demographics.
| Patient characteristics | HCC (N = 62) | CLD controls (N = 177) | All controls* (N = 377) | P-value (HCC vs. CLD controls) |
|---|---|---|---|---|
| Age, years, mean (SD) | 63.7 (10.0) | 59.7 (13.0) | 56.9 (14.8) | P < 0.0001 |
| Sex, n (%) | P = 0.038 | |||
| Female | 17 (27.4) | 77 (43.5) | 224 (59.4) | |
| Male | 45 (72.6) | 100 (56.5) | 153 (40.6) | |
| Weight, kg, mean (SD) | 65.6 (11.3) | 65.5 (14.1) | 63.0 (13.0) | P < 0.0001 |
| BMI, mean (SD) | 25.4 (3.5) | 25.0 (4.5) | 24.4 (4.3) | P < 0.0001 |
| Healthy control, n (%) | 0 (0.0) | 0 (0.0) | 200 (53.1) | - |
| Disease etiology, n (%) | P < 0.001 | |||
| Cirrhosis | 38 (61.3) | 60 (33.9) | 60 (15.9) | |
| No cirrhosis | 24 (38.7) | 117 (66.1) | 317 (84.1) | |
| HBV | 40 (64.5) | 78 (44.1) | 78 (20.7) | |
| HCV | 20 (32.3) | 99 (55.9) | 99 (26.3) | |
| Non-HBV/HCV | 2 (3.2) | 0 (0.0) | 200 (53.1) | |
| BCLC stage, n (%) | ||||
| 0 | 9 (14.5) | - | - | - |
| A | 24 (38.7) | - | - | - |
| B | 13 (21.0) | - | - | - |
| C | 16 (25.8) | - | - | - |
| Biomarker/algorithm values, mean (range) | ||||
| AFP, ng/mL | 2,401.8 (1.48–60,138) | 5.98 (0.60–79.41) | 4.32 (0.60–79.4) | P = 0.064 |
| AFP-L3, ng/mL | 62.53 (1.20–1,000) | 1.36 (1.20–5.32) | 1.28 (1.20–5.32) | P = 0.012 |
| PIVKA-II, ng/mL | 770.75 (13.17–10,108) | 23.95 (3.78–319.60) | 20.04 (3.78–319.60) | P = 0.0027 |
| GAAD, score | 5.37 (0.14–10) | 1.12 (0.028–8.34) | 0.76 (0.01–8.34) | P < 0.0001 |
| GALAD, score | 5.49 (0.16–10) | 1.17 (0.031–8.33) | 0.78 (0.02–8.33) | P < 0.0001 |
*All controls included healthy controls (n = 200) and CLD controls (n = 177). P-values were calculated based on chi-squared tests for categorical variables and t-tests for numeric variables. AFP, α-fetoprotein; AFP-L3, Lens culinaris agglutinin-reactive fraction of α-fetoprotein; BCLC, Barcelona Clinic Liver Cancer; BMI, body mass index; CLD, chronic liver disease; GAAD, gender (biological sex), age, AFP, PIVKA-II; GALAD, gender (biological sex), age, AFP-L3, AFP, PIVKA-II; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; PIVKA-II, protein induced by vitamin K absence or antagonist II; SD, standard deviation.