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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
1,079 Previous Clinical Trials
335,480 Total Patients Enrolled
5 Trials studying Liver Cancer
225 Patients Enrolled for Liver Cancer
Fred Hutchinson Cancer CenterOTHER
557 Previous Clinical Trials
1,338,015 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,048,235 Total Patients Enrolled
3 Trials studying Liver Cancer
106 Patients Enrolled for Liver Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study admit participants below the age of thirty?

"This research project is welcoming participants over the age of 18 and under 85."

Answered by AI

Is there an opportunity to participate in this research endeavor?

"To qualify for this hepatocellular carcinoma study, patients should be between 18 and 85 years old. This trial is currently recruiting a total of 5500 participants."

Answered by AI

Has the FDA endorsed semi-annual GALAD monitoring for Arm B?

"The safety of Arm B: Semi-annual surveillance using GALAD is rated a 3 on the 1 to 3 scale as this Phase 4 trial has already been approved."

Answered by AI

How many medical facilities are participating in this investigation?

"This trial is conducted in a variety of locations, including the University of California at San Francisco, Indiana University in Indianapolis, and Massachusetts General Hospital in Boston. Additionally, there are 8 other sites participating as well."

Answered by AI

Are there any available openings in this study?

"According to records hosted on clinicaltrials.gov, this specific medical trial is not actively recruiting patients anymore. The study was first posted on January 1st 2024 and the latest update was recorded October 10th 2023; nevertheless, 1155 other trials are enlisting participants as of present moment."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
National Liver Cancer Screening Trial
Amit Singal 2023. "National Liver Cancer Screening Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084234.
All > Liver Fibrosis > Hepatocellular Carcinoma
~3667 spots leftby Dec 2029
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