Abdominal Ultrasound Screening with serum AFP for Carcinoma, Hepatocellular

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, WA
Carcinoma, Hepatocellular+2 More
Abdominal Ultrasound Screening with serum AFP - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The study is a randomized trial of two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver. The goal of PREMIUM is to compare an abbreviated version of the diagnostic gold standard for HCC (aMRI) +AFP to the standard-of-care screening (US+AFP) in patients at high risk of developing HCC. The investigators hypothesize that HCC will be detected at earlier stages, allowing for more curative treatments and resulting in a reduction in HCC-related mortality.

Eligible Conditions

  • Carcinoma, Hepatocellular
  • Cirrhosis of the Liver

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Hepatocellular

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 8 years

8 years
Hepatocellular Carcinoma Mortality
Overall Survival
Receipt of potentially curative treatments for Hepatocellular Carcinoma
Stage of Hepatocellular Carcinoma at diagnosis

Trial Safety

Safety Progress

1 of 3

Other trials for Carcinoma, Hepatocellular

Trial Design

1 Treatment Group

Abdominal Ultrasound Screening with serum AFP
1 of 1
Active Control

4700 Total Participants · 1 Treatment Group

Primary Treatment: Abdominal Ultrasound Screening with serum AFP · No Placebo Group · N/A

Abdominal Ultrasound Screening with serum AFP
Other
ActiveComparator Group · 1 Intervention: Abdominal Ultrasound Screening with serum AFP · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 years
Closest Location: VA Puget Sound Health Care System Seattle Division, Seattle, WA · Seattle, WA
Photo of Seattle 1Photo of Seattle 2Photo of Seattle 3
2003First Recorded Clinical Trial
1 TrialsResearching Carcinoma, Hepatocellular
53 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,744,213 Total Patients Enrolled
2 Trials studying Carcinoma, Hepatocellular
11 Patients Enrolled for Carcinoma, Hepatocellular
George N. Ioannou, MD MSStudy ChairVA Puget Sound Health Care System Seattle Division, Seattle, WA

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have radiologic evidence of portal hypertension.
You have signs of cirrhosis.
You have a score of 3.25 or less on the FIB-4 test within 6 months of randomization.
You are a female age 18-75 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.