Status:
RECRUITING
Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) and Image Tools for Early Detection of Hepatocellular Carcinoma
Lead Sponsor:
Korea University
Collaborating Sponsors:
Korea University Ansan Hospital
Soonchunhyang University Hospital
Conditions:
Liver Cirrhosis
Hepatocellular Carcinoma
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief Summary
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 cirrh...
Detailed 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 abdomina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
1418 Patients enrolled
Trial Details
Trial ID
NCT04414956
Start Date
July 1 2016
End Date
February 28 2026
Last Update
June 4 2020
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea, 15355
2
The Catholic University of Korea Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea, 11765
3
Keimyung University Dongsan Medical Center
Daegu, South Korea, 42601
4
Inje University SangGye Paik Hospital
Seoul, South Korea, 01757