A Study of HCC High Risk Group Using Two Surveillance Tools

NCT02675920 | Completed DMC

• 1 other identifier: SNUH-2013-2284
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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

HCC

Keywords

surveillance; ultrasonography; computed tomography

Outcome Measures

Primary Outcomes (1)

• Detection rate of patients with HCC

  from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening

  18 months

Secondary Outcomes (2)

• Detection rate of patients with early HCC

  18 months

• False referral rate

  18 months

Other Outcomes (1)

• radiation dose per patient

  12 months

Study Arms (1)

High risk group of HCC

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.

Drug: non-ionic monomer iodinated CT contrast media

Interventions

non-ionic monomer iodinated CT contrast media DRUG

patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)

Also known as: contrast enhanced CT

High risk group of HCC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at high risk of HCC AND High Risk Index (\>=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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Taejoon Pharmaceutical Co., Ltd.: collaborator
• Reyon Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 5, 2016
• Study Start: November 28, 2014
• Primary Completion: January 11, 2019
• Study Completion: October 1, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)