NCT03460080

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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

February 12, 2018

Last Update Submit

March 2, 2018

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaAFP-L3PIVKA-II

Outcome Measures

Primary Outcomes (1)

  • PIVKA-II

    Using PIVKA-II assay kit (chemiluminescent microparticle immunoassay)

    Day one

Secondary Outcomes (9)

  • Alpha-Fetoprotein (AFP)

    Day one

  • Alpha-Fetoprotein-L3% (AFP-L3%)

    Day one

  • Alanine Aminotransferase (ALT)

    Day one

  • Aspartate Aminotransferase (AST)

    Day one

  • Gamma Glutamyl Transferase (γ-GT)

    Day one

  • +4 more secondary outcomes

Study Arms (2)

Hepatocellular carcinoma patients

Serum samples are collected before liver resection.

Diagnostic Test: AFP-L3 and PIVKA-II in HCC

Hepatic hemangioma patients

Diagnostic Test: AFP-L3 and PIVKA-II in HCC

Interventions

AFP-L3 and PIVKA-II in HCCDIAGNOSTIC_TEST

Serum samples are tested for tumor markers including PIVKA-II, AFP, AFP-L3% and biochemical tests. Imaging: CT or MRI

Hepatic hemangioma patientsHepatocellular carcinoma patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The participants will be recruited through outpatient clinics and inpatient in Hanoi Medical University Hospital.

You may qualify if:

  • Age between 18 and 85
  • Receiving no treatment before diagnosis
  • Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012.

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

Study Sites (1)

Hanoi Medical University

Hanoi, 100000, Vietnam

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Science Research and International Cooperation Unit

Study Record Dates

First Submitted

February 12, 2018

First Posted

March 9, 2018

Study Start

January 1, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

VN(1)