RECRUITING

National Liver Cancer Screening Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.

Official Title

National Liver Cancer Screening Trial

Quick Facts

Study Start:2023-12-26
Study Completion:2034-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06084234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Amit Singal, MD, MS
CONTACT
214.645.6216
Amit.Singal@UTSouthwestern.edu
Sneha Deodhar, MS
CONTACT
214.645.1378
Sneha.Deodhar@UTSouthwestern.edu

Principal Investigator

Amit Singal, MD, MS
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90089
United States
University of California, San Francisco
San Francisco, California, 94117
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
The Feinstein Institutes, Northwell Health, Inc.
Manhasset, New York, 11030
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
UT Southwestern Medical Center and Parkland Hospital
Dallas, Texas, 75390
United States
Baylor College of Medicine
Houston, Texas, 77021
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Amit Singal, MD, MS, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-26
Study Completion Date2034-12-31

Study Record Updates

Study Start Date2023-12-26
Study Completion Date2034-12-31

Terms related to this study

Keywords Provided by Researchers

  • Hepatocellular carcinoma surveillance
  • GALAD
  • Alpha Fetoprotein

Additional Relevant MeSH Terms

  • Carcinoma, Hepatocellular
  • Liver Cancer
  • Liver Cirrhosis
  • Hepatitis B