Evidence map›Paper›PMID 40624654›Full record

Observational studyClinical epigenetics2025

Clinical performance evaluation of a plasma dual-target methylation test for the detection of primary liver cancer: a multicenter study.

Zhigao Xu, Wanping Chen, Hongsheng Wei, Kui Tan, Lianglu Zhang, Lanlan Dong, Wenjin Liang, Xin Zhou, Tao Zhang, Jian Chen and 4 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Clinical epigenetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Zhigao Xu *Institute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, National Quality Control Center for Donated Organ Procurement, Hubei Key Laboratory of Medical Technology on Transplantation, Hubei Clinical Research Center for Natural Polymer Biological Liver, Zhongnan Hospital of Wuhan University, Wuhan, 430071, Hubei, China.
Wanping Chen *Department of Hepatobiliary Surgery, Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University), Changsha, 410005, Hunan, China.
Hongsheng Wei *Laboratory Department, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, Anhui, China.
Kui Tan *The Second Department of Clinical Laboratory, Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University), Changsha, 410005, Hunan, China.
Lianglu ZhangWuhan Ammunition Life-tech Company, Ltd., Wuhan, 430206, Hubei, China.
Lanlan DongWuhan Ammunition Life-tech Company, Ltd., Wuhan, 430206, Hubei, China.
Wenjin LiangInstitute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, National Quality Control Center for Donated Organ Procurement, Hubei Key Laboratory of Medical Technology on Transplantation, Hubei Clinical Research Center for Natural Polymer Biological Liver, Zhongnan Hospital of Wuhan University, Wuhan, 430071, Hubei, China.
Xin ZhouInstitute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, National Quality Control Center for Donated Organ Procurement, Hubei Key Laboratory of Medical Technology on Transplantation, Hubei Clinical Research Center for Natural Polymer Biological Liver, Zhongnan Hospital of Wuhan University, Wuhan, 430071, Hubei, China.
Tao ZhangInstitute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, National Quality Control Center for Donated Organ Procurement, Hubei Key Laboratory of Medical Technology on Transplantation, Hubei Clinical Research Center for Natural Polymer Biological Liver, Zhongnan Hospital of Wuhan University, Wuhan, 430071, Hubei, China.
Jian ChenThe Second Department of Clinical Laboratory, Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University), Changsha, 410005, Hunan, China. chenjian9240@126.com.
Chuang PengDepartment of Hepatobiliary Surgery, Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University), Changsha, 410005, Hunan, China. 1518364280@qq.com.
Zhongxin WangLaboratory Department, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, Anhui, China. aywzhx87@163.com.
Shaojun YeInstitute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, National Quality Control Center for Donated Organ Procurement, Hubei Key Laboratory of Medical Technology on Transplantation, Hubei Clinical Research Center for Natural Polymer Biological Liver, Zhongnan Hospital of Wuhan University, Wuhan, 430071, Hubei, China. ZN001582@whu.edu.cn.
Qifa YeInstitute of Hepatobiliary Diseases of Wuhan University, Transplant Center of Wuhan University, National Quality Control Center for Donated Organ Procurement, Hubei Key Laboratory of Medical Technology on Transplantation, Hubei Clinical Research Center for Natural Polymer Biological Liver, Zhongnan Hospital of Wuhan University, Wuhan, 430071, Hubei, China. yqf_china@163.com.

Funding

Zhongnan Hospital of Wuhan University LCYFMS2024010
6 · The paper itself

Abstract

backgroundPrimary liver cancer (PLC) is a global health concern. The plasma dual-target methylation (PDTM) test, which interrogates the methylation status of GNB4 and Riplet, exhibits a commendable ability to discriminate hepatocellular carcinoma (HCC) from controls. Nevertheless, its performance in detecting PLC in larger populations remains to be validated.

resultsA multicenter, double-blind, cross-sectional study was conducted. Blood samples were collected from all participants for the PDTM test, which is based on a triplex quantitative methylation-specific polymerase chain reaction (qMSP) platform. Additionally, Sanger sequencing was performed to confirm the accuracy of methylation detection by the PDTM test. The study enrolled 430 PLC patients and 752 controls. The PDTM test demonstrated an overall sensitivity of 92.3% (95% confidence interval [CI], 89.4-94.7) for PLC patients and an overall specificity of 93.4% (95% CI, 91.3-95.0) for controls with benign liver disease (BLD) or non-liver primary malignancies (NLPM). Specifically, the sensitivities of the PDTM test for patients with HCC, intrahepatic cholangiocarcinoma (ICC) or early-stage (TNM stages I and II) PLC were 91.9% (95% CI, 87.6-95.0), 93.3% (95% CI, 85.9-97.5) and 88.7% (95% CI, 83.9-92.5), respectively. Furthermore, the kappa values for both GNB4 and Riplet between the PDTM test and Sanger sequencing exceeded 0.99, indicating a high level of consistency.

conclusionsThe PDTM test demonstrates excellent diagnostic performance for PLC, particularly in cases of early-stage PLC. It is a promising early screening or surveillance tool for PLC, and further prospective research is required to ascertain its full utility.

Indexed as

Carcinoma, HepatocellularDNA MethylationLiver NeoplasmsAdultAgedBiomarkers, TumorCase-Control StudiesCross-Sectional StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedSensitivity and SpecificityBiomarkers, TumorDNA methylationGNB4Primary liver cancer diagnosisRiplet

Identifiers

PMID40624654
PMCPMC12235875

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.