AzTrials
AzTrials

HCCNCT06728293

Effect of the HCC Liver-Link Intervention

A study testing Liver Link in people with HCC and Racial Disparities, run by Indiana University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC, Racial Disparities
What is being tested?
Liver Link
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
10 Jun 2025to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Within UCSF criteria:
  • Candidates are eligible or a standardized MELD or PELD exception if, before completing locoregional therapy, they have lesions that meet one of the following criteria:
  • One Class 5 lesion greater than 5 cm and less than or equal to 8 cm
  • two or three Class 5 lesions that meeting all of the following
  • At least one lesion greater than 3cm
  • Each lesion less than or equal to 5 cm, and
Show all 16Show fewer
  • A total diameter of all lesions less than or equal to 8cm
  • Four or five Class 5 lesions each less than 3 cm, and a total diameter of all lesions less than or equal to 8 cm.
  • Between 18-75 years old
  • Have no more than two visits with an HCC-related provider
  • Able to read, write, and speak English
  • Any 1 of the following:
  • Self-report as Black race (can be multiple races as long as 1 is Black)
  • Self-report as insured by Medicaid (+/- Medicare)
  • SVI (Social vulnerability index) >= .75
  • Unmarried

Who cannot join

  • Lacks capacity to provide informed consent, including those with stage 2 HE or higher at the time of consent.
  • Age over 75
  • Last transthoracic echocardiogram with EF<40% (OK if no prior echo)
  • BMI over 50
  • Patients who, in the investigator's judgment, are unlikely to ever be eligible for liver transplantation or resection at the time of enrollment, with reason documented
  • Prior history of any solid organ transplant
Show all 9Show fewer
  • Non-skin cancer malignancies other than hepatocellular carcinoma in past 2 years unless approved by PI (i.e. cervical cancer, early prostate cancer)
  • Patients who have undergone resection or waitlisted
  • Patients near completion of transplant evaluation, PI to determine utility of intervention.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Savannah Yarnelle contact

(317) 278-6424

samussel@iu.edu

Regina Weber contact

(317) 278-3584

reginaw@iu.edu

United States2 sites, 2 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21218

    Aly T Strauss, MD, 410-614-1982, astraus6@jhmi.edu

    Aly T Strauss, MD

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

    Anaiya Crowner, (317) 274-0481, acrowner@iu.edu

    Lauren Nephew, MD

    Recruiting

Other trials in United States

About this study

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.

Being tested
Liver Link

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver LinkOther

    Support Program

Study groups in NCT06728293
Study groupRoleWhat they receive
Liver-Link ArmExperimentalThose randomized to the Liver-Link portion of the study will proceed through the Liver-Link component intervention. Participation in this study will last 6 months. Participants in this group are assessed for knowledge of their disease, quality of life, substance use, and for social needs at the beginning of the program. Those who screen positive for social needs or high-risk alcohol will see social work. Participants will attend 3 support groups and compelte exit surveys. Participants will have 3 milestone checks during the 6 month study period and will be referred back to social work if they do not meet milestones. Participants will also have a knowledge assessment after a total of 2 HCC-related visits.
Receives: Other: Liver Link
Standard of Care ArmNo interventionIndividuals in the standard of care portion of the study will complete several questionnaires at the enrollment visit . Over the duration of study participation (6 months), participants in this arm may meet with a social worker as part of their standard health care treatment and will receive education via these standard of care visits. After at least two visits related to HCC clinical care, and participants in this arm will be contacted and will be asked to complete the knowledge assessment tool. At tne end of study they will complete exit survieys via redcap or phone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to waitlist

    Days from study enrollment to liver transplant waitlisting, assessed using OTTR.

    Measured: Up to 6 months post-enrollment

  2. Time to resection

    Days from study enrollment to surgical resection, assessed using EMR.

    Measured: Up to 6 months post-enrollment

  3. Waitlisting or Resection

    Proportion of participants who achieve liver transplant waitlisting or surgical resection, assessed using EMR and OTTR

    Measured: Up to 6 months post-enrollment

  4. Time to Death

    Days from study enrollment to death, assessed using EMR and OTTR.

    Measured: Up to 6 months post-enrollment

Secondary outcomes (4)

  1. HCC-Related Knowledge

    Score on a 10-item internally developed HCC knowledge multiple-choice test.

    Measured: Baseline and 6 months post-enrollment.

  2. Medical Mistrust

    Score on 7-item Medical Mistrust Index.

    Measured: Baseline and 6 months post-enrollment.

  3. Social Needs and AUD Linkage

    Percentage of participants offered services for a social need, achieving improvement in a social need, and without alcohol use in the past 90 days; assessed by patient and social worker reports in REDCap.

    Measured: Up to 6 months post-enrollment.

  4. Quality of Life (QOL)

    Composite and domain-specific scores (anxiety, depression, social role participation) on PROMIS-29 QOL Tool.

    Measured: Baseline and 6 months post-enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start10 Jun 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
20 patients will then be randomized to SOC and 20 to the Liver-Link Intervention. Randomization will be stratified by race and SES.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728293
Sponsor's protocol ID
23696
Other IDs
5K23MD018090
Status last verified
May 2026
First submitted
25 Nov 2024
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Liver Link in people with HCC and Racial Disparities, run by Indiana University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Savannah Yarnelle ((317) 278-6424, samussel@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to waitlist (time frame: Up to 6 months post-enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06728293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in