Clinical Trials Logo

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC.

Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to:

- Group 1: Usual care, with visit-based HCC screening per discretion of individual providers

- Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource intensity)

- Group 3: Mailed HCC screening invitation outreach to eligible patients combined with centralized patient navigation to promote screening completion and follow-up (high resource intensity)

Through three specific aims, this effectiveness research randomized controlled trial will:

- Aim 1: Engage stakeholders in design and implementation of HCC screening outreach interventions.

- Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention strategies to increase completion of one-time and repeat HCC screening.

- Aim 3: Evaluate whether intervention effects are moderated by patient sex, race, ethnicity, English proficiency, and connectedness to primary care.

The screening intervention strategies combine EMR-enabled case identification, system-level screening outreach, and patient navigation to improve identification of previously unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up of abnormal screening tests. This study will engage stakeholders throughout the research process, evaluate the effectiveness and acceptability of HCC screening strategies, and determine which patient subgroups benefit the most.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02312817
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase N/A
Start date December 2014
Completion date August 2017

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
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 NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
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