Status:
COMPLETED
RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Parkland Health and Hospital System
Conditions:
Carcinoma, Hepatocellular
Liver Neoplasms
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 underg...
Eligibility Criteria
Inclusion
- As the risk of HCC is significant in those with cirrhosis regardless of age, gender, or race, we will include adult patients with cirrhosis of all ages (\> 21 years old), both sexes, and all races/ethnicities who speak English or Spanish.
- Our study leverages Parkland's electronic medical record (EMR) and uses a novel EMR-enabled case-finding algorithm to identify patients with known cirrhosis, using ICD-9 codes, as well as those with unrecognized but suspected cirrhosis, using a set of laboratory data.
- Patients with ICD-9 codes for cirrhosis or cirrhosis complication will be eligible for study enrollment if they meet the following criteria:
- One or more encounter with ICD-9 codes 456.0, 456.1, 456.2, 456.21, 567.23, 572.2, 572.3, and 572.4; OR,
- Two or more encounters with ICD-9 codes 571.2 and/or 571.5; OR,
- One encounter with ICD-9 codes 571.2 or 571.5 from a Parkland primary care clinic, GI, or women's health center.
- Patients with an AST to platelet ratio index (APRI) \> 1.5 in combination with a platelet count \< 300, and aspartate aminotransferase (AST) \< 1,000 during study enrollment will be eligible.
- We will exclude patients who have known HCC or a suspicious appearing mass on imaging within six months prior to ascertainment of eligibility, as these patients require further diagnostic testing instead of routine screening. We will exclude patients with Child Pugh class C cirrhosis or other significant comorbid conditions with a life expectancy less than one year, (e.g., extrahepatic malignancy) because HCC screening is not recommended in these subgroups of patients.
- Parkland patients ≥ 21 years of age
- Diagnosis of cirrhosis or meets criteria for suspected cirrhosis
- ≥ 1 outpatient visit during 12 months prior to randomization
- Contact information on file
- English or Spanish speaking
Exclusion
- HCC or suspicious mass on imaging
- Any malignancy except malignant neoplasm of skin
- Metastatic solid tumor
- Palliative care referral
- Liver transplant
- Child Pugh C
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT02312817
Start Date
December 1 2014
End Date
August 1 2017
Last Update
July 15 2025
Active Locations (1)
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1
Parkland Health & Hospital System
Dallas, Texas, United States, 75235