Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
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ClinicalTrials.gov Identifier: NCT02582918 |
Recruitment Status :
Completed
First Posted : October 21, 2015
Last Update Posted : September 28, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | October 13, 2015 | ||||
First Posted Date ICMJE | October 21, 2015 | ||||
Last Update Posted Date | September 28, 2022 | ||||
Actual Study Start Date ICMJE | March 26, 2018 | ||||
Actual Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Early HCC [ Time Frame: 3 years post randomization ] HCC will be defined by AASLD criteria and staged by Barcelona Clinic Liver Cancer (BCLC) system.
Tumors >1 cm can be diagnosed if CT/MRI shows characteristic findings (arterial enhancement and delayed washout).
Biopsy may be needed if imaging is not diagnostic.
Early HCC will be defined as BCLC stage A tumors that are amenable to curative therapy.
HCC diagnoses and stage will be ascertained from EMR data and confirmed by site investigators.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5 | ||||
Official Title ICMJE | Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion | ||||
Brief 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). | ||||
Detailed 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:
The Specific Aims are:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Screening |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Outreach with patient education and patient navigation services
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Study Arms ICMJE |
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Publications * | Singal 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
2871 | ||||
Original Estimated Enrollment ICMJE |
3000 | ||||
Actual Study Completion Date ICMJE | June 30, 2022 | ||||
Actual Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02582918 | ||||
Other Study ID Numbers ICMJE | 062015-054 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Amit Singal, University of Texas Southwestern Medical Center | ||||
Original Responsible Party | University of Texas Southwestern Medical Center | ||||
Current Study Sponsor ICMJE | University of Texas Southwestern Medical Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Texas Southwestern Medical Center | ||||
Verification Date | September 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |