Recruiting

HCC Liver-Link

Sponsor:

Indiana University

Code:

NCT06728293

Conditions

HCC

Racial Disparities

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Liver Link

Study Details

Brief 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. 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

HCC

Racial Disparities

Study ID

NCT06728293

Start date

Jun 10, 2025

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

• 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
  • 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

Exclusion Criteria

  • 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
  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Liver-Link Arm

Those 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.

no intervention: Standard of Care Arm

Individuals 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.

Interventions

Liver Link

Support Program

Primary outcome measure

  • Time to waitlist [ Time Frame: Up to 6 months post-enrollment ]
  • Time to resection [ Time Frame: Up to 6 months post-enrollment ]
  • Waitlisting or Resection [ Time Frame: Up to 6 months post-enrollment ]
  • Time to Death [ Time Frame: Up to 6 months post-enrollment ]

Central Contacts and Locations

Central contacts

Savannah Yarnelle

(317) 278-6424samussel@iu.edu

Regina Weber

(317) 278-3584reginaw@iu.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Anaiya Crowner

(317) 274-0481acrowner@iu.edu

Principal Investigator:

Lauren Nephew, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Aly T Strauss, MD

410-614-1982astraus6@jhmi.edu

Principal Investigator:

Aly T Strauss, MD

More Information

Sponsor

Indiana University

Last update posted

Jun 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-05.