NCT03645655

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

August 20, 2018

Last Update Submit

July 16, 2021

Conditions

HepatoblastomaHepatic Hemangioendothelioma

Keywords

hepatoblastomaHepatic HemangioendotheliomaProtein induced by vitamin K absence or antagonist-IIAlpha-fetoproteininfantDifferential diagnosis

Outcome Measures

Primary Outcomes (1)

  • Change of PIVKA-II

    Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).

    Baseline Time, Postoperative Day 1

Secondary Outcomes (1)

  • Change of AFP

    Baseline Time, Postoperative Day 1

Study Arms (3)

hepatoblastoma

The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology.

Diagnostic Test: PIVKA-II

hepatic hemangioendothelioma

The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology.

Diagnostic Test: PIVKA-II

Healthy control

The healthy control group consist of people undergoing routine medical examination.

Interventions

PIVKA-IIDIAGNOSTIC_TEST

Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.

Also known as: DCP
hepatic hemangioendotheliomahepatoblastoma

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The participants will be recruited through inpatient department.

You may qualify if:

  • Age between 1 month and 12 month
  • Receiving no treatment before diagnosis
  • With written informed consent

You may not qualify if:

  • Clinical data missing
  • Serum samples doesn't qualified
  • Vitamin K absence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • 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.

    PMID: 38622445DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood was collected from each patient prior to any treatment (surgery and/or chemotherapy)

MeSH Terms

Conditions

Hepatoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Min Xu, Doctor

    Shanghai Children's Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 24, 2018

Study Start

October 1, 2018

Primary Completion

September 30, 2020

Study Completion

June 30, 2021

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

CN(1)