Clinical trial · Observational
PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants
PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants: Protocol for a Multicenter, Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Although hepatic tumors are uncommon in the perinatal period they are associated with significant morbidity and mortality in affected patients. The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(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 are consecutively recruited into the cohort. 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 and biochemical indexes including alanine aminotransferase(ALT), aspartate aminotransferase(AST), gamma-glutamyl transferase(GGT), alpha-l-fucosidase(AFU), etc.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Hemangioendothelioma | — | UNRESOLVED | — |
| Hepatoblastoma | Hepatoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIVKA-II | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- hepatoblastoma
- description
- The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology.
- interventionNames
- Diagnostic Test: PIVKA-II
- label
- hepatic hemangioendothelioma
- description
- The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology.
- interventionNames
- Diagnostic Test: PIVKA-II
- label
- Healthy control
- description
- The healthy control group consist of people undergoing routine medical examination.
Primary outcomes (1)
- measure
- Change of PIVKA-II
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 12 Months
Show eligibility criteria text
Inclusion Criteria: * Age between 1 month and 12 month * Receiving no treatment before diagnosis * With written informed consent Exclusion Criteria: * Clinical data missing * Serum samples doesn't qualified * Vitamin K absence
References
Publications (1)
- DERIVEDGao 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. PMID 38622445