Clinical trial · Observational
A Study of HCC High Risk Group Using Two Surveillance Tools
A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study
NCT02675920CI-TRIAL-00047563completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-ionic monomer iodinated CT contrast media | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- High risk group of HCC
- description
- known high risk group of HCC according to AASLD guideline. And patients whose risk index is equal to or higher than 2.33. Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus \[HCV\] or hepatitis B surface antigen \[HBsAg\] is positive). Patients undergo ultrasonography and LDCT using non-ionic monomer iodinated CT contrast media biannually and the interval between ultrasound and LDCT is within 30 days.
- interventionNames
- Drug: non-ionic monomer iodinated CT contrast media
Primary outcomes (1)
- measure
- Detection rate of patients with HCC
- timeFrame
- 18 months
- description
- from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: All conditions have to be satisfied to be enrolled. * \> 20 years * high risk group of HCC according to AASLD guideline * risk index \> = 2.33 * currently on regular biannual surveillance using ultrasonography * sign informed consent Exclusion Criteria: Patients with any of following condition cannot be enrolled. * previously diagnosed with HCC * any contraindication of contrast enhanced CT including allergic reaction to iodine * history of other malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.