Clinical verification of an improved assay of "NX-PVKA-R", which associated with des-gamma-carboxyprothrombin, for diagnosis of patients with hepatocellular carcinoma

Clinical verification of an improved assay of "NX-PVKA-R", which associated with des-gamma-carboxyprothrombin, for diagnosis of patients with hepatocellular carcinoma - Clinical verification of an improved assay of "NX-PVKA-R" for HCC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007196

Enrollment

Registered

2012-02-01

Start date

2010-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with chronic hepatitis, hepatocirrhosis, or treatment-naive hepatocellular carcinoma. 2. Protein induced by vitamin K absence or antagonist-II (PIVKA-II) is measured by the conventional method. The patients, whose level of PIVKA-II was higher than 40mU/mL or lower or equal to 40mU/mL, can enroll for this study.

Exclusion criteria

Exclusion criteria: 1. The patients who have poorly controlled cardiovascular, hematologic or pulmonary disease 2. The patients with pregnancy 3. The patients with severe depression or other psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of PIVKA-II, NX-PVKA, NX-PVKA-R and AFP to diagnose HCC	—

Countries

Japan

Contacts

Public ContactYoichi Hiasa

Ehime University Graduate School of Medicine Department of Gastroenterology and Metabology

hiasa@m.ehime-u.ac.jp+81-89-960-5308

Outcome results