Table 1 Biomarkers
From: New insights into biomarkers and risk stratification to predict hepatocellular cancer
Biomarker | Study type, No. of subjects, and Biomarker development phase | Sensitivity (%) | Specificity (%) | Cut-off | AUROC | Ref. | Notes* |
|---|---|---|---|---|---|---|---|
AFP | Prospective (n = 2331), phase 3 | 38.4 | 90 | 8.6 ng/mL | 0.72 | PMID: 38899967 El-Serag et al., 2024 | Cirrhosis any etiology, HCC |
AFP | Prospective (n = 534), phase 3 | 34.6–38.2 | 90 | 10.8–11.2 ng/mL | 0.71–0.78 | PMID: 35124267 Tayob et al. 2023 | Cirrhosis any etiology, HCC |
AFP | Prospective (n = 397), transition from phase 2 to 3 | 50 | 90 | 17.4 ng/mL | 0.77 | PMID: 34618932 Singal et al. 2022b | Cirrhosis any etiology, HCC |
AFP | Prospective (n = 1084), phase 2 | 42.4 | 94.9 | 20 ng/mL | 0.844 | PMID: 37938100 Piratvisuth et al. 2023 | Chronic liver disease (> 77% viral etiology), HCC |
AFP | Retro/prospective (n = 437), phase 2 | 43 | 98 | 20 ng/mL | 0.81 | PMID: 32889146 Chalasani et al. 2021 | Liver disease any etiology (> 87.4 cirrhosis) and HCC |
AFP | Prospective (n = 163), phase 2 | 75 | 93.5 | 14.2 ng/mL | 0.869 | PMID: 36013482 Hadi et al. 2022 | Non-cirrhosis and cirrhosis with etiology (HBV/HCV/MASH), HCC |
AFP | Prospective (n = 1120), phase 2 | 44.8 | 76.1 | 20 ng/mL | 0.692 | PMID: 31358576 Cai et al. 2019 | HBV, cirrhosis and HCC |
AFP | Prospective (n = 288), phase 3 | 29.2 | 87.4 | 20 ng/mL | 0.59 | PMID: 37708457 Beudeker et al. 2023 | European cirrhosis and HCC |
AFP | Prospective (n = 284), phase 3 | 34.5 | 92.4 | 20 ng/mL | 0.66 | PMID: 37708457 Beudeker et al. 2023 | Latin America cirrhosis and HCC |
AFP-L3 | Prospective (n = 2331), phase 3 | 37.6 | 90 | 7.5% | 0.61 | PMID: 38899967 El-Serag et al., 2024 | Cirrhosis any etiology, HCC |
AFP-L3 | Prospective (n = 534), phase 3 | 34.6–41.2 | 90 | 8.3–8.4% | 0.64–0.81 | PMID: 35124267 Tayob et al. 2023 | Cirrhosis any etiology, HCC |
AFP-L3 | Prospective (n = 397), transition from phase 2 to 3 | 46.2 | 90 | 11.9% | 0.80 | PMID: 34618932 Singal et al. 2022b | Cirrhosis any etiology, HCC |
AFP-L3 | Prospective (n = 288), phase 3 | 30.4 | 81.1 | 10% | 0.56 | PMID: 37708457 Beudeker et al. 2023 | European cirrhosis and HCC |
AFP-L3 | Prospective (n = 284), phase 3 | 46.6 | 91.7 | 10% | 0.69 | PMID: 37708457 Beudeker et al. 2023 | Latin America cirrhosis and HCC |
AFP-L3 | Retro/prospective (n = 437), phase 2 | 56 | 93 | 10% | 0.81 | PMID: 32889146 Chalasani et al. 2021 | Liver disease any etiology (> 87.4 cirrhosis) and HCC |
DCP | Prospective (n = 2331), phase 3 | 30.4 | 90 | 2.91 ng/mL | 0.75 | PMID: 38899967 El-Serag et al., 2024 | Cirrhosis any etiology, HCC |
DCP | Prospective (n = 534), phase 3 | 17.6–23.1 | 90 | 1.4–1.5 ng/mL | 0.68–0.72 | PMID: 35124267 Tayob et al. 2023 | Cirrhosis any etiology, HCC |
DCP | Prospective (n = 288), phase 3 | 26.7 | 87.4 | 7.5 ng/mL | 0.57 | PMID: 37708457 Beudeker et al. 2023 | European cirrhosis and HCC |
DCP | Prospective (n = 284), phase 3 | 36.2 | 97.4 | 7.5 ng/mL | 0.65 | PMID: 37708457 Beudeker et al. 2023 | Latin America cirrhosis and HCC |
DCP | Prospective (n = 397), transition from phase 2 to 3 | 34.6 | 90 | 5.9 ng/mL | 0.70 | PMID: 34618932 Singal et al. 2022b | Cirrhosis any etiology, HCC |
DCP | Prospective (n = 1084), phase 2 | 61.3 | 88.7 | 20 ng/mL | 0.772 | PMID: 37938100 Piratvisuth et al. 2023 | Chronic liver disease (> 77% viral etiology), HCC |
DCP | Retro/prospective (n = 437), phase 2 | 39 | 93 | 7.5 ng/mL | 0.83 | PMID: 32889146 Chalasani et al. 2021 | Liver disease any etiology (> 87.4 cirrhosis) and HCC |
DCP | Prospective (n = 163), phase 2 | 90 | 82.1 | 36.7 mAU/mL | 0.905 | PMID: 36013482 Hadi et al. 2022 | Non-cirrhosis and cirrhosis with etiology (HBV/HCV/MASH), HCC |
DCP | Retrospective (n = 186), phase 2 | 72 | 71 | 7 ng/mL | 0.715 | PMID: 38994169 He et al. 2024 | Healthy control and AFP-negative HCC |
OPN | Retrospective (n = 322), phase 2 | 79.2 | 79.6 | - | 0.85 | PMID: 32043608 Zhu et al. 2020 | Chronic hepatitis, cirrhosis, and HCC |
MDK | Meta-analysis of 9 studies | 87 | 86 | 0.5 ng/mL | 0.95 | PMID: 31600291 Zhang et al. 2019 | HCC |
MDK | Meta-analysis of 17 studies | 84 | 82 | - | 0.89 | PMID: 32039435 Lu et al. 2020 | HCC |
GP73 | Retrospective (n = 186), phase 2 | 75.6 | 93 | 103 ng/mL | 0.843 | PMID: 38994169 He et al. 2024 | Healthy control and AFP-negative HCC |
GPC3 | Retrospective (n = 344), phase 2 | 80 | 85 | 0.0414 ng/mL | 0.88 | PMID:32087138 Liu et al. 2020 | Healthy control and HCC |
TGF-β1 | Prospective | 53.1% | 98.9% | 50 ug/ g-1 creatinine | 0.730 | PMID: 9166938 Tsai et al. 1997 | Cirrhosis (74.4% viral etiology), HCC |
SCCA-IgM | Prospective | 89% | 50% | 130 AU/mL | 0.63 | PMID:24635038 Pozzan et al. 2014 | Cirrhosis, healthy control, and HCC |