Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

Hepatocellular cancer (HCC) is the most common (≥ 95%) of liver cancers. HCC is also the fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas residents notably Hispanics and African Americans are greatly affected with established HCC risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease. Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic fatty liver disease (NAFLD), are exceptionally common in Texans. The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and suffering related to liver cancer in Texas and the world through five research projects. This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized controlled trial of strategies to increase HCC surveillance. This is the first multi-center outreach intervention aimed at improving surveillance process completion among at-risk patients with cirrhosis. This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. Across these 3 sites, we 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. This study uses an EMR-enabled case-finding algorithm to identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized cirrhosis, using laboratory data. Over 3000 patients identified by this algorithm will be randomized to: - Group 1: Usual care with opportunistic visit-based HCC surveillance. - Group 2: Mailed HCC surveillance outreach with patient education and patient navigation services. The Specific Aims are: - Aim 1: Compare the clinical effectiveness of the intervention strategies to increase completion of the HCC surveillance process. - Aim 2: Compare patient-reported satisfaction and acceptability of the HCC surveillance strategies. - Aim 3: Evaluate whether intervention effects are moderated by patient sex, race/ethnicity, socioeconomic status, health care utilization, and documented vs. unrecognized cirrhosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02582918
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase N/A
Start date March 26, 2018
Completion date June 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT03289533 - A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100) Phase 1
Terminated NCT01141478 - Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria N/A
Recruiting NCT05580835 - PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma N/A
Active, not recruiting NCT05389527 - Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma Phase 2
Not yet recruiting NCT04560751 - TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)
Withdrawn NCT02939807 - A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma Phase 2
Completed NCT01915602 - Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC) Phase 2
Completed NCT04970212 - Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
Recruiting NCT02403544 - Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma Phase 1
Completed NCT01897038 - A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma Phase 1
Terminated NCT01337492 - Pilot Study Sorafenib as Bridge to Orthotopic Liver Transplantation (OLT) Phase 0
Completed NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
Terminated NCT01020812 - Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma Phase 1/Phase 2
Completed NCT01003015 - Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma Phase 2
Completed NCT00559455 - Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma Phase 2
Recruiting NCT00384800 - A Phase II Study of Tegafur/Uracil (UFUR®)Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC) Phase 2
Terminated NCT00582400 - A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver Phase 2
Completed NCT00056992 - Testing of ADI-PEG in Hepatocellular Carcinoma Phase 2
Completed NCT02859324 - A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC) Phase 1/Phase 2
Terminated NCT02439008 - Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response N/A