Kit for early screening of hepatocellular carcinoma and preparation method and application thereof
A technology of hepatocellular carcinoma and kit, which is applied in the field of kits for early screening of hepatocellular carcinoma, and can solve the problem of positive predictive value in HCC prediction
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Embodiment 1
[0185] Example 1 Follow-up of Clinical Parameters and Hepatocellular Carcinoma (HCC) Outcomes of Participants at Baseline in Four Screening Centers
[0186]Community-based individuals (n = 72,720) were screened by blood hepatitis B surface antigen (HBsAg) testing at four screening centers, followed by a questionnaire survey. HBsAg-positive individuals (n=3,793) were invited to participate in AFP / US screening. Of these HBsAg-positive individuals, 176 had relevant AFP / US results (designated the AFP / US-positive / suspect group), while the remaining HBsAg-positive patients constituted the AFP / US-negative group (n=3,617) ( figure 1 and Table 6). To determine their HCC status, dynamic CT / MRI is recommended for all AFP / US positive / suspect individuals within 2 months of initial screening. Those with a reliable diagnosis of HCC status were included as the training set for this study, and HCC screening tests were performed on baseline AFP / US screening blood samples obtained from these i...
Embodiment 2
[0188] Example 2 Selection and detection of HCC markers for HCC screening
[0189] The present invention develops an HCC screening assay using two classes of biomarkers: 1) genetic alterations that are very prevalent in HCC and can be detected in cfDNA; and 2) the serum protein markers AFP and desγ-carboxyprothrombin (DCP) . In previous cancer genome studies, most HBV-associated HCC carried at least one mutation in the following genes / locations: TP53, CTNNB1, AXIN1 or TERT promoter (Totoki Y, et al. (2014) Trans-ancestry mutational landscape of hepatocellular carcinoma genomes . Nature genetics 46(12):1267-1273; Zhang W, et al. (2017) Genetic Features of Aflatoxin-associated Hepatocellular Carcinomas. Gastroenterology.). The present invention also considers HBV integration breakpoints as potential biomarkers for HCC. Since HBV integration sites should be unique in each individual cell, detection of multiple copies (>2) of a particular integration site from plasma (2–3 ml) ca...
Embodiment 3
[0191] Example 3 Consistency of Clinical Diagnosis with HCC Screening Assays
[0192] To determine its utility in the detection of HCC, the present invention evaluated the HCC screening assay in individuals known to have been diagnosed with HCC or had been ruled out (non-HCC). Sixty-five HCC and 70 non-HCC cases were obtained from AFP / US positive / suspect individuals. The HCC-positive or HCC-negative status is based on dynamic CT / MRI imaging and histological confirmation. These 135 cases were used as a training set, and HCC screening results were compared with clinical diagnoses. To build a classifier integrating different types of biomarkers in an assay, the present invention first collapses different types of cfDNA mutations into region of interest (ROI) fractions for each gene or locus. The ROI score is a weighted sum of the disruptive effect and frequency of each point mutation within the ROI. In addition to the ROI fraction for SNV / indel mutations in genes, the present ...
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Abstract
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