National Liver Cancer Screening Trial (TRACER)
N
Naga Chalasani, MD
Primary Investigator
Enrolling By Invitation
18-85 years
All
Phase
N/A
10 participants needed
3 Locations
Brief description of study
What is this study about?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What happens during the study?
Patients will be randomly assigned to one of two study arms:
1) Arm A: Semi-annual surveillance using liver US ± AFP or
2) Arm B: Semi-annual surveillance using GALAD
- For patients randomized to US ± AFP surveillance, US ± AFP will be offered per usual care by
- clinical providers as this is current standard of care.
- For patients randomized to GALAD-based surveillance, GALAD will be ordered by study team every 6 months +/- 3 months.
- Neither arm includes any patient navigation (e.g., reminder calls, scheduling assistance, rescheduling for missed appointments) beyond routine clinical practice.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hepatocellular Carcinoma, Hepatitis B Liver Cancer, Liver Cirrhosis
-
Age: Between 18 Years - 85 Years
-
Gender: All
Inclusion criteria:
1 Adult patients ages 18-85 with cirrhosis from any etiology (see Table 1) or with chronic
hepatitis B with a PAGE-B score greater than 9 within 12 months of consent
2 Patient is eligible for HCC surveillance according to treating physician or by the site
investigator
3 Able to provide informed consent
4 Life expectancy >6 months (after consent) as determined by the treating provider or site
investigator
1 Adult patients ages 18-85 with cirrhosis from any etiology (see Table 1) or with chronic
hepatitis B with a PAGE-B score greater than 9 within 12 months of consent
2 Patient is eligible for HCC surveillance according to treating physician or by the site
investigator
3 Able to provide informed consent
4 Life expectancy >6 months (after consent) as determined by the treating provider or site
investigator
Updated on
28 Sep 2024.
Study ID: GI-NCI-TRACER, 21013
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