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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5.5 years
Awards & highlights

TRACER 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.Check my eligibility
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.See study design
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.

TRACER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18-85 years old with cirrhosis or chronic hepatitis B and a PAGE-B score over 9.

TRACER Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of HCC detected at late stage
Secondary outcome measures
HCC Screening utilization
Incidence of late-stage HCC
Number of participants who encountered screening related Psychological harm
+4 more

TRACER 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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,080 Previous Clinical Trials
335,430 Total Patients Enrolled
5 Trials studying Liver Cancer
225 Patients Enrolled for Liver Cancer
University of PennsylvaniaOTHER
2,015 Previous Clinical Trials
42,868,526 Total Patients Enrolled
2 Trials studying Liver Cancer
665 Patients Enrolled for Liver Cancer
Fred Hutchinson Cancer CenterOTHER
557 Previous Clinical Trials
1,337,978 Total Patients Enrolled
~3667 spots leftby Dec 2029
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