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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03460080
Date of registration:	12/02/2018
Prospective Registration:	No
Primary sponsor:	Hanoi Medical University
Public title:	Diagnostic Value of AFP-L3 and PIVKA-II in HCC
Scientific title:	Diagnostic Value of AFP-L3 and PIVKA-II in HCC
Date of first enrolment:	January 1, 2018
Target sample size:	200
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT03460080
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Vietnam

Contacts

Name:	Bui My Hanh, MD
Address:
Telephone:	+84983070973
Email:	buimyhanh@hmu.edu.vn
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma

Intervention(s)

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

Primary Outcome(s)

PIVKA-II [Time Frame: Day one]

Secondary Outcome(s)

Albumin [Time Frame: Day one]

Alpha-Fetoprotein (AFP) [Time Frame: Day one]

Antibodies to Hepatitis C virus (Anti HCV) [Time Frame: Day one]

Alpha-Fetoprotein-L3% (AFP-L3%) [Time Frame: Day one]

Hepatitis B virus surface antigen (HBsAg) [Time Frame: Day one]

Alanine Aminotransferase (ALT) [Time Frame: Day one]

Gamma Glutamyl Transferase (?-GT) [Time Frame: Day one]

Aspartate Aminotransferase (AST) [Time Frame: Day one]

Prothrombin Time (PT) (%) [Time Frame: Day one]

Secondary ID(s)

HMU16222

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bach Mai Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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