National Liver Cancer Screening Trial

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• GALAD — DIAGNOSTIC_TEST
  GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.
• Liver Ultrasound with or without AFP — DIAGNOSTIC_TEST
  This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.

Study Details

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.

Key Dates

Start date

Dec 26, 2023

Status verified

Nov 2025

Primary completion

Dec 31, 2029

Completion

Dec 31, 2034

Study Design

Enrollment

5,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Active Comparator: Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoprotein
  Participants in this arm will undergo current standard of care surveillance procedures i.e. liver ultrasound with or without alpha fetoprotein (AFP) measurement.
• Experimental: Arm B: Semi-annual surveillance using GALAD
  For participants in this arm, study team will order GALAD measurement every 6 months +/- 3 months.

Primary Outcome Measure

Proportion of HCC detected at late stage [ Time Frame: 5.5 years ]

Central Contacts

• Amit Singal, MD, MS
  214.645.8821
  [email protected]
• Sneha Deodhar, MS
  214.645.1378
  [email protected]

Locations (18)

Find similar trials in Los Angeles, CA

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