Clinical trial · Observational
Diagnostic Value of AFP-L3 and PIVKA-II in HCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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 alpha-fetoprotein-L3 (AFP-L3) and Protein Induced by Vitamin K Absence or antagonist-II (PIVKA-II). This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. 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, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AFP-L3 and PIVKA-II in HCC | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hepatocellular carcinoma patients
- description
- Serum samples are collected before liver resection.
- interventionNames
- Diagnostic Test: AFP-L3 and PIVKA-II in HCC
- label
- Hepatic hemangioma patients
- interventionNames
- Diagnostic Test: AFP-L3 and PIVKA-II in HCC
Primary outcomes (1)
- measure
- PIVKA-II
- timeFrame
- Day one
- description
- Using PIVKA-II assay kit (chemiluminescent microparticle immunoassay)
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 85 * Receiving no treatment before diagnosis * Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012. Exclusion Criteria: * Clinical data missing * Laboratory tests information missing * Serum samples doesn't qualified * Obstructive jaundice patients * Medical history of taking warfarin
References
Publications (0)
Data not yet available