Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) and Image Tools for Early Detection of Hepatocellular Carcinoma

K

Korea University

Status

Enrolling

Conditions

Surveillance
Liver Cirrhosis
Hepatocellular Carcinoma

Treatments

Diagnostic Test: Sonography
Diagnostic Test: CT
Diagnostic Test: AFP-L3
Diagnostic Test: PIVKA-II
Diagnostic Test: AFP

Study type

Interventional

Funder types

Other

Identifiers

NCT04414956
HCCAFPL3

Details and patient eligibility

About

In this study, three biomarkers tests (AFP, AFP-L3 and PIVKA-II) and abdominal sonography or CT scans are performed every 6 months to detect hepatocellular carcinoma (HCC) early in patients with cirrhosis, a high-risk group of HCC. The aim of this study is to confirm the early HCC diagnosis rate in patients with cirrhosis and compare the detection efficacy between tests.

Full description

Early diagnosis of HCC is the most important factor in improving the prognosis of the disease. A surveillance test for early diagnosis of HCC in Korea is to perform alfa fetoprotein (AFP) and abdominal sonography every 6-months in high-risk groups. However, the detection rate of HCC using AFP and abdominal sonography is very low. There are several reports that the combination of the multiple biomarker tests including AFP, AFP L3, and PIVKA-II increased the early HCC detection only one test. Therefore, in the surveillance test for HCC, the combination of three tests with sonography would be helpful in the early diagnosis of HCC. However, there was few prospective large-scale studies about this issue. Compared with abdominal sonography, contrast-enhanced CT or MRI is more useful in finding intrahepatic lesions of liver cirrhosis. However, there is no evidence data on combining sono/CT and biomarkers could improve the diagnosis for early HCC. Thus, it is essential to verify this prospectively in the real clinical practices to make recommendations based on a high level of evidence in the future. The investigators are conducting a prospective study which examines three biomarker tests and sonography every six months and contrast-enhanced CT annually for HCC surveillance in patients with cirrhosis.

Enrollment

1,418 estimated patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with liver cirrhosis meeting one of the followings:

    i. Histologically confirmed liver cirrhosis ii. Imaging findings with liver cirrhosis (liver surface undulation, irregularity, or nodularity by US, CT, or MRI) plus one of followings: liver stiffness measurement ≥ 12.5 kilopascal, esophago-gastric varices, thrombocytopenia (<120,000/mm3), hypoalbuminemia (<3.5 g/dL), splenomegaly ≥12 cm) iii. Imaging findings with liver cirrhosis together with biomarkers suggesting liver cirrhosis (APRI ≥2.0 or fibrosis-4 ≥3.6) iv. Imaging findings with liver cirrhosis with history of hepatic decompensation (ascites, esophago-gastric variceal bleeding, jaundice, hepatic encephalopathy))

  • Expected survival more than 1 year

  • Child Pugh score 5-10 at the time of enrollment

  • Serum creatinine ≤1.5mg/dL

  • Age between 19 and 75 years old

  • No significant underlying medical illness affecting patient's survival

  • Patients available for regular follow-up according to the study protocol

Exclusion criteria

  • History of HCC
  • AFP >20 ng/mL
  • Hepatic nodule ≥ 1 cm by US or CT Exceptionally, nodules showing characteristic features of benign lesion such as hemangioma or pathologically conformed benign lesion are permitted for study inclusion.
  • Hepatic nodule less than 1 cm on US but imaging findings suggesting HCC by contrast enhanced US, CT, or MRI
  • Child-Pugh score ≥ 11
  • History of liver transplantation
  • Expecting liver transplantation within 1 year
  • Hypersensitivity on CT contrast dye
  • Any contraindication for CT
  • Not able to perform abdominal US
  • Other uncontrolled malignancy
  • Patients taking warfarin

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,418 participants in 1 patient group

Surveillance
Other group
Description:
All participants will be examined with three biomarker tests and sonography every six months and contrast-enhanced CT annually.
Treatment:
Diagnostic Test: PIVKA-II
Diagnostic Test: AFP
Diagnostic Test: AFP-L3
Diagnostic Test: CT
Diagnostic Test: Sonography

Trial contacts and locations

15

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Central trial contact

Soon Ho Um, MD,PhD; Hyung Joon Yim, MD,PhD

Data sourced from clinicaltrials.gov

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