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Biomarker-based Screening

Biomarker Screening for Liver Cancer (TRACER Trial)

Phase 4

Recruiting

Led By Amit Singal, MD, MS

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment

Be older than 18 years old

Must not have

Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)

History of a transjugular intrahepatic portosystemic shunt (TIPS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5.5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares ultrasound and biomarker-based methods to screen 5500 people with cirrhosis/hepatitis B for hepatocellular carcinoma. Results assessed after 5.5 years.

Who is the study for?

Adults aged 18-85 with liver cirrhosis of any cause or chronic hepatitis B (with specific risk score) can join this trial. They must be able to consent, have a life expectancy over 6 months, and be eligible for liver cancer surveillance. Exclusions include severe cirrhosis, symptoms or history of certain liver cancers, high AFP levels without clear scans, other active cancers (except some under surveillance), planned MRI/CT-based surveillance, recent serious alcohol-related liver disease.

What is being tested?

The trial is testing two ways to screen for liver cancer in at-risk patients: Arm A uses ultrasound and a blood test called AFP every six months; Arm B uses a biomarker scoring system called GALAD on the same schedule. The goal is to see which method is better at catching late-stage hepatocellular carcinoma early.

What are the potential side effects?

Since the interventions are screening methods involving ultrasound and blood tests rather than medications or invasive procedures, side effects are minimal but may include discomfort from the ultrasound procedure and potential bruising or rare complications from blood draws.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18-85 years old with cirrhosis or chronic hepatitis B and a PAGE-B score over 9.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing symptoms of acute Wilson disease.

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I have had a procedure to connect two veins in my liver.

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I have liver disease related to my Fontan procedure.

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I have had a solid organ transplant.

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I am currently taking warfarin.

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My liver disease is severe (Child-Pugh C).

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I have or had symptoms of liver or bile duct cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of HCC detected at late stage

Secondary study objectives

HCC Screening utilization

Incidence of late-stage HCC

Number of participants who encountered screening related Psychological harm

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Semi-annual surveillance using GALADExperimental Treatment1 Intervention

For participants in this arm, study team will order GALAD measurement every 6 months +/- 3 months.

Group II: Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoproteinActive Control1 Intervention

Participants in this arm will undergo current standard of care surveillance procedures i.e. liver ultrasound with or without alpha fetoprotein (AFP) measurement.

0 / 8Eligibility criteria met