Actively Recruiting
Effect of the HCC Liver-Link Intervention
Led by Indiana University · Updated on 2025-09-15
40
Participants Needed
2
Research Sites
50 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a pilot, multi-center randomized controlled trial testing the HCC Liver-Link intervention, a culturally tailored, multi-level program designed to reduce racial disparities in hepatocellular carcinoma (HCC) care. The intervention combines: (1) patient education to improve HCC-related disease and treatment knowledge, (2) social needs and substance use screening with referral to social work and community resources, and (3) facilitated access to subspecialty cancer care through a multidisciplinary HCC tumor board. A total of 40 Black patients with Barcelona Clinic Liver Cancer (BCLC) stage 0, A, or downstaged B disease will be randomized to receive either the HCC Liver-Link intervention or usual care and followed for 6 months or until liver transplant waitlisting. Primary outcomes are time to receipt of curative therapies (liver transplantation or resection) and change in HCC-related knowledge. Findings will inform development of larger interventions to eliminate racial disparities in HCC outcomes.
CONDITIONS
Official Title
Effect of the HCC Liver-Link Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Within UCSF criteria for liver transplant eligibility with specific lesion size and number limits
- Between 18 and 75 years old
- No more than two visits with an HCC-related provider
- Able to read, write, and speak English
- Self-report as Black race, or have Medicaid insurance, or have social vulnerability index ≥ 0.75, or be unmarried
You will not qualify if you...
- Unable to provide informed consent including those with stage 2 hepatic encephalopathy or higher
- Age over 75
- Last transthoracic echocardiogram with ejection fraction less than 40% (if echo done)
- Body mass index over 50
- Unlikely to be eligible for liver transplantation or resection at enrollment as judged by investigator
- Prior history of any solid organ transplant
- History of non-skin cancer malignancies other than HCC in past 2 years unless approved by investigator
- Patients who have undergone resection or are already waitlisted for transplant
- Patients near completion of transplant evaluation as determined by principal investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
Research Team
S
Savannah Yarnelle
CONTACT
R
Regina Weber
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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