Using biomarkers and imaging tools to detect liver cancer early in patients with cirrhosis
Clinical Usefulness of Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) With Abdominal Sonography or Computed Tomography for Early Detection of Hepatocellular Carcinoma
This study is testing a new way to find liver cancer earlier in people with cirrhosis by using a combination of blood tests and imaging scans done every six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1418 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Korea University Academic / other |
| Locations | 15 sites (Ansan, Gyeonggi-do and 14 other locations) |
| Trial ID | NCT04414956 on ClinicalTrials.gov |
What this trial studies
This study aims to improve early detection of hepatocellular carcinoma (HCC) in patients with liver cirrhosis by combining three biomarker tests (AFP, AFP-L3, and PIVKA-II) with abdominal sonography and CT scans. Participants will undergo these tests every six months to evaluate the effectiveness of this combined approach in diagnosing HCC at an earlier stage. The study seeks to provide evidence on whether this multi-faceted surveillance strategy can enhance detection rates compared to standard methods. By conducting this prospective study, the researchers hope to establish a more reliable protocol for HCC surveillance in high-risk patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 to 75 with liver cirrhosis and a life expectancy of more than one year.
Not a fit: Patients with significant underlying medical conditions affecting survival or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve early diagnosis rates of hepatocellular carcinoma, leading to better patient outcomes.
How similar studies have performed: While there have been few large-scale prospective studies on this specific combination of tests, similar approaches using multiple biomarkers have shown promise in enhancing early cancer detection.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ansan, Gyeonggi-do and 14 other locations
- Korea University Ansan Hospital — Ansan, Gyeonggi-do, Korea, Republic of (Recruiting)
- The Catholic University of Korea Uijeongbu St.Mary's Hospital — Uijeongbu, Gyeonggi-do, Korea, Republic of (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, Korea, Republic of (Recruiting)
- Inje University SangGye Paik Hospital — Seoul, Korea, Republic of (Recruiting)
- Korea University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- Soonchunhyang University Seoul Hospital — Seoul, Korea, Republic of (Recruiting)
- Hanyang University Hospital — Seoul, Korea, Republic of (Recruiting)
- Konkuk University Hospital — Seoul, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea Seoul St.Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
- Chung-Ang University Hosptial — Seoul, Korea, Republic of (Recruiting)
- Korea University Guro Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hyung Joon Yim, MD,PhD
- Email: gudwns21@korea.ac.kr
- Phone: +82-31-412-6565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.