Evaluation of Diagnostic Efficiency of PIVKA-II and Other Tumor Markers in HCC
Evaluation of Diagnostic and Differential Diagnostic Significance of a Combination of PIVKA-II and Other Tumor Markers in Hepatocellular Carcinoma
1 other identifier
observational
4,005
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2019
CompletedFebruary 20, 2024
February 1, 2024
2.3 years
February 6, 2017
February 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PIVKA-II
Using PIVKA-II assay kit(chemiluminescent microparticle immunoassay).
Day one
Secondary Outcomes (2)
AFP,AFP-L3%
Day one
ALT, AST，γ-GT， AFU
Day one
Study Arms (4)
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.
Interventions
Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests.
Eligibility Criteria
The participants will be recruited through outpatient clinics.
You may qualify if:
- Age between 18 and 85
- Receiving no treatment before diagnosis
- Establishing Diagnosis according to the Asian Pacific Association for the Study of Liver(APASL) criteria
You may not qualify if:
- Clinical data missing
- Laboratory tests information missing
- Serum samples doesn't qualified
- Obstructive jaundice patients
- Medical history of taking warfarin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eastern Hepatobiliary Surgery Hospitallead
- Abbott Diagnostics Divisioncollaborator
- Peking University First Hospitalcollaborator
- The First Hospital of Jilin Universitycollaborator
- RenJi Hospitalcollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Gansu Provincial Hospitalcollaborator
- Henan Provincial People's Hospitalcollaborator
- Sun Yat-sen Universitycollaborator
- Sichuan Provincial People's Hospitalcollaborator
Study Sites (1)
Eastern hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, 200438, China
Related Publications (3)
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.
PMID: 31672853DERIVEDYan 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.
PMID: 29448045DERIVEDYan 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.
PMID: 29129627DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor,Associate professor
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 9, 2017
Study Start
May 1, 2016
Primary Completion
September 1, 2018
Study Completion
March 20, 2019
Last Updated
February 20, 2024
Record last verified: 2024-02