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HepaClear, a blood-based panel combining novel methylated CpG sites and protein markers, for the detection of
Yi Bai1, Juan Xu2, Deqiang Li3
1Department of Hepatobiliary Surgery, Tianjin First Central Hospital, School of Medicine, Nankai University, Tianjin, China.
Insights
A new blood test, HepaClear, shows high sensitivity for early hepatocellular carcinoma (HCC) detection. This diagnostic panel improves upon existing markers for earlier and more accurate cancer screening in at-risk individuals.
Area of Science:
- Oncology
- Molecular Diagnostics
- Biomarker Discovery
Background:
- Early detection of hepatocellular carcinoma (HCC) is crucial for improving patient outcomes.
- Existing screening methods have limitations in sensitivity and specificity for early-stage disease.
Purpose of the Study:
- To identify novel hypermethylated DNA markers for HCC.
- To develop a blood-based diagnostic panel (HepaClear) combining DNA methylation and protein markers for enhanced early-stage HCC detection.
Main Methods:
- Genome-wide methylation arrays were performed on HCC tissue samples.
- Candidate hypermethylated CpG sites were validated using quantitative methylation-specific PCR.
- A panel including 3 CpG sites and 2 protein markers (AFP, DCP) was developed and tested in plasma samples.
Main Results:
- The HepaClear panel demonstrated high sensitivity (82.6% training, 84.7% validation) and specificity (96.2% training, 92.0% validation).
- HepaClear showed superior sensitivity for early-stage HCC compared to AFP and DCP alone.
- The panel successfully detected a significant proportion of AFP-negative HCC cases.
Conclusions:
- A novel multimarker panel, HepaClear, has been developed for sensitive early-stage HCC detection.
- HepaClear holds significant potential for HCC screening and diagnosis in populations at risk.
Background:
Early screening and detection of hepatocellular carcinoma (HCC) can efficiently improve patient prognosis. We aimed to identify a series of hypermethylated DNA markers and develop a blood-based HCC diagnosis panel containing DNA methylation sites and protein markers with improved sensitivity for early-stage HCC detection.
Results:
Overall, 850K methylation arrays were performed using paired tissue DNA samples from 60 HCC patients. Ten candidate hypermethylated CpG sites were selected for further evaluation by quantitative methylation-specific PCR with 60 pairs of tissue samples. Six methylated CpG sites, along with α-fetoprotein (AFP) and des-gamma-carboxyprothrombin (DCP), were assayed in 150 plasma samples. Finally, an HCC diagnosis panel, named HepaClear, was developed in a cohort consisting of 296 plasma samples and validated in an independent cohort consisting of 198 plasma samples. The HepaClear panel, containing 3 hypermethylated CpG sites (cg14263942, cg12701184, and cg14570307) and 2 protein markers (AFP and DCP), yielded a sensitivity of 82.6% and a specificity of 96.2% in the training set and a sensitivity of 84.7% and a specificity of 92.0% in the validation set. The HepaClear panel had higher sensitivity (72.0%) for early-stage HCC than AFP (≥ 20 ng/mL, 48.0%) and DCP (≥ 40 mAU/mL, 62.0%) and detected 67.5% of AFP-negative HCC patients (AFP ≤ 20 ng/mL).
Conclusions:
We developed a multimarker HCC detection panel (HepaClear) that shows high sensitivity for early-stage HCC. The HepaClear panel exhibits high potential for HCC screening and diagnosis from an at-risk population.
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