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| Name | Class |
|---|---|
| Abbott Diagnostics Division | INDUSTRY |
| Peking University First Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| RenJi Hospital |
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The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC cases were at advanced stage when the diagnosis established.Early diagnosis improves the prognosis.The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II). This study is a international multicenter study joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including healthy control,HCC,metastatic liver cancer,Hepatitis B virus(HBV) and liver cirrhosis are consecutively recruited into the cohort. All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II,alpha-fetoprotein and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl transferase(GGT),alpha-l-fucosidase(AFU),etc.
Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide.Early diagnosis improves the prognosis. 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. The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II). PIVKA-II as an effective tumor marker for hepatocellular carcinoma(HCC) has been widely used in the western countries where most cases are hepatitis C virus(HCV) related.However, the majority of HCCs in China are HBV related. Despite the extensive application of PIVKA-II in some hospitals from China, the diagnostic efficiency including sensitivity,specificity,positive predictive value and negative predictive value still needs more clinical data to evaluate. The research purposes list as follows:1.Determination of diagnostic Cut-off value 2.Evaluation of diagnostic efficiency of PIVKA-II 3.Evaluation of the combination of PIVKA-II and other tumor markers for HCC. This study is an international multicenter study joined by several hospitals in China,Singapore,Thailand and Vietnam. Participants including healthy control,HCC,metastatic liver cancer,HBV and liver cirrhosis are consecutively recruited into the cohort. All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II,Alpha-fetoprotein(AFP),alpha-fetoprotein L3 and biochemical indexes including ALT,AST,GGT,AFU,etc. The diagnosis of HCC was based on histopathology. All HCC diagnoses were confirmed at the time of analysis.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 performance characteristic of PIVKA-II,AFP,AFP-L3 measurement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control | The healthy control group consist of people undergoing routine medical examination. Serum samples are collected. |
| |
| Metastatic liver cancer patients | Serum samples are collected. |
| |
| Hepatocellular carcinoma patients | Serum samples are collected before liver resection. |
| |
| Chronic liver disease patients | This group is comprised of liver cirrhosis and chronic hepatitis B patients. The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIVKA-II | Diagnostic Test | Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PIVKA-II | Using PIVKA-II assay kit(chemiluminescent microparticle immunoassay). | Day one |
| Measure | Description | Time Frame |
|---|---|---|
| AFP,AFP-L3% | Day one | |
| ALT, AST,γ-GT, AFU | Day one |
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Inclusion Criteria:
Exclusion Criteria:
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The participants will be recruited through outpatient clinics.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern hepatobiliary surgery hospital | Shanghai | Shanghai Municipality | 200438 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31672853 | Derived | Yang T, Xing H, Wang G, Wang N, Liu M, Yan C, Li H, Wei L, Li S, Fan Z, Shi M, Chen W, Cai S, Pawlik TM, Soh A, Beshiri A, Lau WY, Wu M, Zheng Y, Shen F. A Novel Online Calculator Based on Serum Biomarkers to Detect Hepatocellular Carcinoma among Patients with Hepatitis B. Clin Chem. 2019 Dec;65(12):1543-1553. doi: 10.1373/clinchem.2019.308965. Epub 2019 Oct 31. | |
| 29448045 |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Gansu Provincial Hospital | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Sun Yat-sen University | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
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|
| Yan C, Hu J, Yang J, Chen Z, Li H, Wei L, Zhang W, Xing H, Sang G, Wang X, Han R, Liu P, Li Z, Li Z, Huang Y, Jiang L, Li S, Dai S, Wang N, Yang Y, Ma L, Soh A, Beshiri A, Shen F, Yang T, Fan Z, Zheng Y, Chen W. Serum ARCHITECT PIVKA-II reference interval in healthy Chinese adults: Sub-analysis from a prospective multicenter study. Clin Biochem. 2018 Apr;54:32-36. doi: 10.1016/j.clinbiochem.2018.02.007. Epub 2018 Feb 12. |
| 29129627 | Derived | Yan C, Yang J, Wei L, Hu J, Song J, Wang X, Han R, Huang Y, Zhang W, Soh A, Beshiri A, Fan Z, Zheng Y, Chen W. Serum reference interval of ARCHITECT alpha-fetoprotein in healthy Chinese Han adults: Sub-analysis of a prospective multi-center study. Clin Biochem. 2018 Feb;52:164-166. doi: 10.1016/j.clinbiochem.2017.11.002. Epub 2017 Nov 10. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |