Clinical trial · Interventional
Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC) surveillance process completion among a socioeconomically and racially diverse cohort of Texans with cirrhosis. Through this project the investigators will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. The study population will include adult patients with documented or unrecognized cirrhosis and at least one outpatient clinic visit in year prior to randomization. Patients will be identified using an EMR-enabled case identification algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or, mailed HCC surveillance outreach with patient education and patient navigation services (Group 2).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Outreach with patient education and patient navigation services | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group 1: Usual Care
- description
- Usual care with opportunistic visit-based HCC surveillance.
- type
- EXPERIMENTAL
- label
- Group 2: Patient Education and Patient Navigation Services
- description
- Mailed HCC surveillance outreach with patient education and patient navigation services.
- interventionNames
- Behavioral: Outreach with patient education and patient navigation services
Primary outcomes (2)
- measure
- Completion of HCC surveillance process
- timeFrame
- 3 years post randomization
- description
- Ascertained through EMR. HCC surveillance process completion will be defined as: * normal ultrasound and AFP every 6 ± 1 months for two consecutive years, * abnormal ultrasound or AFP ≥20 ng/mL and follow-up diagnostic CT or MRI without HCC, then appropriate surveillance as indicated for total of 2 years, or * abnormal ultrasound or AFP, HCC detected on CT/MRI, and timely HCC treatment consultation. Effective surveillance requires repeat testing every 6 months in patients with normal tests to maximize sensitivity while minimizing patient burden. Patients with abnormal surveillance tests (i.e. liver mass on ultrasound or AFP ≥20 ng/mL) require 4-phase CT or MRI within 3 months, with a 3-month cut-off based on HCC tumor doubling time. Patients with non-contrast imaging, two-phase CT, or imaging \> 3 months after abnormal tests will be coded as failure. Likewise, patients with HCC confirmed on CT/MRI will need HCC-directed treatment within 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>21 years old) * Documented cirrhosis * Unrecognized cirrhosis * An outpatient visit in year prior to randomization * English or Spanish speaking Exclusion Criteria: * History of HCC * History of liver transplantation * Child Pugh C cirrhosis * Significant comorbid conditions with life expectancy \< 1 year, (e.g., extrahepatic malignancy)
References
Publications (4)
- DERIVEDPatel A, Gavrila E, Yekkaluri S, Hoshida Y, Hernaez R, Singal AG. Net benefit of surveillance varies by hepatocellular carcinoma risk in patients with cirrhosis. JHEP Rep. 2026 Mar 25;8(8):101831. doi: 10.1016/j.jhepr.2026.101831. Online ahead of print. PMID 41895663
- DERIVEDSingal AG, Daher D, Narasimman M, Yekkaluri S, Liu Y, Cerda V, Banala C, Khan A, Lee M, Seif El Dahan K, Murphy CC, Kramer JR, Hernaez R. Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial. J Natl Cancer Inst. 2025 Feb 1;117(2):262-269. doi: 10.1093/jnci/djae228. PMID 39288308
- DERIVEDSingal AG, Narasimman M, Daher D, Yekkaluri S, Liu Y, Lee M, Cerda V, Khan A, Seif El Dahan K, Kramer J, Gopal P, Murphy C, Hernaez R. Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial. Gut. 2024 Nov 11;73(12):2037-2044. doi: 10.1136/gutjnl-2024-332508. PMID 38839269
- DERIVEDSingal AG, Reddy S, Radadiya Aka Patel H, Villarreal D, Khan A, Liu Y, Cerda V, Rich NE, Murphy CC, Tiro JA, Kramer JR, Hernaez R. Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2818-2825.e1. doi: 10.1016/j.cgh.2021.12.014. Epub 2021 Dec 10. PMID 34902568