PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants
NCT ID: NCT03645655
Last Updated: 2021-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
257 participants
OBSERVATIONAL
2018-10-01
2021-06-30
Brief Summary
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Detailed Description
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Protein induced by vitamin K antagonist-II (PIVKA-II), also known as des-γ-carboxyprothrombin (DCP) or acarboxy prothrombin, is an abnormal form of prothrombin induced by vitamin K absence or antagonist-II. An elevated serum level of PIVKA-II is reported to be associated with hepatocellular (HCC). Many studies have shown that PIVKA-II is applicable for HCC surveillance and has been written into the guideline of JSH, which achieves remarkably good results.
The study is intended to evaluate diagnostic and differential diagnostic accuracy of PIVKA-II combining with alpha-fetoprotein in hepatic tumor of infant.
This study is a multicenter study joined by several hospitals in China. Participants including hepatoblastoma, hepatic hemangioendothelioma and healthy control. All the serum samples are collected before and after each treatment and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II, Alpha-fetoprotein(AFP)， and biochemical indexes including ALT, AST, GGT, AFU, etc. The diagnosis of hepatoblastoma and hepatic hemangioendothelioma was based on enhanced CT scanning and/or histopathology. The Student's t-test (or Mann-Whitney test) was used to compare continuous variables, and the chi-square test (or Fisher's exact test) was used for categorical variables. A receiver operator characteristic (ROC) curve was used to assess the diagnostic and differential diagnostic efficiency of PIVKA-II and the combined tumor markers with AFP.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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hepatoblastoma
The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology.
PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
hepatic hemangioendothelioma
The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology.
PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
Healthy control
The healthy control group consist of people undergoing routine medical examination.
No interventions assigned to this group
Interventions
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PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving no treatment before diagnosis
* With written informed consent
Exclusion Criteria
* Serum samples doesn't qualified
* Vitamin K absence
1 Month
12 Months
ALL
Yes
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Chidren's Hospital of Fudan University
UNKNOWN
Chongqing Children's Hospital, Chongqing Medical University
UNKNOWN
Children's Hospital of Nanjing Medical University
OTHER
Qilu Children's Hospital of Shandong University
OTHER
Anhui Children's Hospital
UNKNOWN
The First Affiliated Hospital of Anhui Medical University
OTHER
Zhengzhou Children's Hospital
UNKNOWN
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Shanghai Children's Medical Center
OTHER
Responsible Party
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Principal Investigators
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Min Xu, Doctor
Role: STUDY_CHAIR
Shanghai Children's Medical Center
Locations
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Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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References
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Gao H, Xie C, Wang J, Ma J, Liu S, Xie L, Zheng Y, Dong R, Wang S, Fang Y, Wu Y, Zhang X, Lu X, Li Y, Li W, Pan Q, Xu M, Gu S. PIVKA-II combined with alpha-fetoprotein for the diagnostic value of hepatic tumors in children: a multicenter, prospective observational study. Hepatol Int. 2024 Aug;18(4):1326-1335. doi: 10.1007/s12072-024-10668-4. Epub 2024 Apr 16.
Other Identifiers
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General surgery of SCMC
Identifier Type: -
Identifier Source: org_study_id
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