Grant Number:	5R01CA212008-06 Interpret this number
Primary Investigator:	Singal, Amit
Organization:	Ut Southwestern Medical Center
Project Title:	Harms of Hepatocellular Carcinoma Screening in Patients with Cirrhosis
Fiscal Year:	2022

PROJECT SUMMARY / ABSTRACT The incidence of hepatocellular carcinoma (HCC) is rising in the U.S and is projected to become the 3rd leading cause of cancer death by 2030. Over 90% of HCC occur in cirrhosis, and HCC is the leading cause of death for these patients. Although several professional societies recommend use of abdominal ultrasound and alpha fetoprotein (AFP), a serum biomarker, every 6 months in patients with cirrhosis, limitations in the literature have precluded consensus recommendations. Two systematic reviews concluded prior studies have notable limitations including a lack of data regarding screening harms. Potential harms of HCC screening include: 1) physical and financial harms from diagnostic evaluation in screen-positive patients (e.g., contrast injury, radiation exposure, biopsy complications); 2) overdiagnosis; and 3) psychosocial harms due to positive or indeterminate screen results. Because the survival benefit of HCC screening appears modest, a comprehensive harms assessment is needed to inform guidelines, build consensus among primary care providers and specialists, and guide patient and provider decision-making about HCC screening. Leveraging a multi-center randomized trial assessing screening benefits in a socioeconomically (~30% underinsured) and racially diverse (>50% Black or Hispanic) population of 3000 patients with cirrhosis followed in 3 healthcare settings (academic tertiary care center, safety-net health system, and Veterans Affairs system) over a 4-year period, we propose to: Aim 1: Assess the effect of HCC screening on a) physical harms due to follow-up tests, b) financial harms, and c) overdiagnosis in patients with severe liver dysfunction or comorbid illness, through electronic medical record data, manual chart review, and validated survey measures Aim 2: Assess the effect of HCC screening on screening-related psychosocial harms, e.g. cancer-specific worry, situational anxiety, mood disturbances, and decisional regret, through longitudinal validated measures and qualitative interviews Aim 3: Create and disseminate a balance sheet of benefits and harms to inform patients, nurses, providers, healthcare organizations, payers, and policymakers about the value of HCC screening in patients with cirrhosis We will use mixed-effect regression analysis to identify if screening-related harms differ by patient, provider, and healthcare system factors. These data will complement concurrently collected data about screening benefits from the randomized trial to provide the highest quality data available about benefits and harms of HCC screening at a time when policy decisions about HCC screening are being made. We will immediately translate our study findings to facilitate patient-provider discussions, inform payer decisions about reimbursement, and guide policy decisions on HCC screening in patients with cirrhosis.




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Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial.
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Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial.
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Financial burden in a US cohort of patients with HCC.
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Proportion of Time Covered by Hepatocellular Carcinoma Surveillance in Patients With Cirrhosis.
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Hepatocellular Carcinoma Screening in a Contemporary Cohort of At-Risk Patients.
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Hepatocellular Carcinoma Surveillance Patterns and Outcomes in Patients With Cirrhosis.
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Hepatocellular carcinoma surveillance may be associated with potential psychological harms in patients with cirrhosis.
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COVID-19 Pandemic Impact on Diagnosis, Stage, and Treatment of Hepatocellular Carcinoma in the United States.
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The financial burden after liver transplantation is significant among commercially insured adults: A large US National Cohort.
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Underuse of HCC Surveillance: Not a Sign of Cynicism.
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Financial Burden of Hepatocellular Carcinoma Screening in Patients with Cirrhosis.
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International Liver Cancer Association (ILCA) white paper on hepatocellular carcinoma risk stratification and surveillance.
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Clinical Outcomes of Patients With Suspicious (LI-RADS 4) Liver Observations.
Authors: Onyirioha K. , Joshi S. , Burkholder D. , Yekkaluri S. , Parikh N.D. , Singal A.G. , North American Liver Cancer (NALC) Consortium .
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Precision HCC Surveillance: It Is All in the Number (Needed).
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PMID: 36302995
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Recall patterns and risk of primary liver cancer for subcentimeter ultrasound liver observations: a multicenter study.
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Hepatocellular carcinoma surveillance in patients with non-alcoholic fatty liver disease.
Authors: Seif El Dahan K. , Daher D. , Singal A.G. .
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Blood-based biomarkers for hepatocellular carcinoma screening: Approaching the end of the ultrasound era?
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Emerging Tools for Hepatocellular Carcinoma Surveillance.
Authors: Singal A.G. , Reig M. , Villanueva A. .
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Reply.
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HCC surveillance improves early detection, curative treatment receipt, and survival in patients with cirrhosis: A meta-analysis.
Authors: Singal A.G. , Zhang E. , Narasimman M. , Rich N.E. , Waljee A.K. , Hoshida Y. , Yang J.D. , Reig M. , Cabibbo G. , Nahon P. , et al. .
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Associations of Ultrasound LI-RADS Visualization Score With Examination, Sonographer, and Radiologist Factors: Retrospective Assessment in Over 10,000 Examinations.
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Early detection of hepatocellular carcinoma: roadmap for improvement.
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Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study.
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Patient Preferences for Hepatocellular Carcinoma Surveillance Parameters.
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Overdiagnosis of hepatocellular carcinoma: Prevented by guidelines?
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Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance.
Authors: Singal A.G. , Reddy S. , Radadiya Aka Patel H. , Villarreal D. , Khan A. , Liu Y. , Cerda V. , Rich N.E. , Murphy C.C. , Tiro J.A. , et al. .
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Risk of Hepatocellular Carcinoma in Patients With Indeterminate (LI-RADS 3) Liver Observations.
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Dynamic Changes in Ultrasound Quality for Hepatocellular Carcinoma Screening in Patients With Cirrhosis.
Authors: Schoenberger H. , Chong N. , Fetzer D.T. , Rich N.E. , Yokoo T. , Khatri G. , Olivares J. , Parikh N.D. , Yopp A.C. , Marrero J.A. , et al. .
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PMID: 34119640
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International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma.
Authors: Singal A.G. , Hoshida Y. , Pinato D.J. , Marrero J. , Nault J.C. , Paradis V. , Tayob N. , Sherman M. , Lim Y.S. , Feng Z. , et al. .
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PMID: 33705745
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Novel Application of Predictive Modeling: A Tailored Approach to Promoting HCC Surveillance in Patients With Cirrhosis.
Authors: Singal A.G. , Chen Y. , Sridhar S. , Mittal V. , Fullington H. , Shaik M. , Waljee A.K. , Tiro J. .
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Reply to: "Challenges associated with the roll-out of HCC surveillance in sub-Saharan Africa - the case of Uganda".
Authors: Singal A.G. , Lampertico P. , Nahon P. .
Source: Journal Of Hepatology, 2020 11; 73(5), p. 1273-1274.
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PMID: 32800586
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Cost-Effectiveness of Hepatocellular Carcinoma Surveillance: An Assessment of Benefits and Harms.
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PMID: 32530829
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Conceptual Model for the Hepatocellular Carcinoma Screening Continuum: Current Status and Research Agenda.
Authors: Singal A.G. , Lok A.S. , Feng Z. , Kanwal F. , Parikh N.D. .
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Benefits and Harms of Hepatocellular Carcinoma Surveillance in a Prospective Cohort of Patients with Cirrhosis.
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PMID: 32920214
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Depression and Anxiety Are Common Among Patients With Cirrhosis.
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Is hepatocellular carcinoma surveillance in high-risk populations effective?
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Patient-Reported Barriers are Associated With Receipt of Hepatocellular Carcinoma Surveillance in a Multicenter Cohort of Patients With Cirrhosis.
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Thrombocytosis is associated with worse survival in patients with hepatocellular carcinoma.
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Hepatocellular carcinoma tumour volume doubling time: a systemic review and meta-analysis.
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Epidemiology and surveillance for hepatocellular carcinoma: New trends.
Authors: Singal A.G. , Lampertico P. , Nahon P. .
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Role of imaging in management of hepatocellular carcinoma: surveillance, diagnosis, and treatment response.
Authors: Osho A. , Rich N.E. , Singal A.G. .
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Harms of hepatocellular carcinoma surveillance.
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Hepatocellular carcinoma surveillance in the 21st century: Saving lives or causing harm?
Authors: Hanouneh I.A. , Alkhouri N. , Singal A.G. .
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Surveillance for Hepatocellular Carcinoma: Current Best Practice and Future Direction.
Authors: Kanwal F. , Singal A.G. .
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AGA Clinical Practice Update on Interaction Between Oral Direct-Acting Antivirals for Chronic Hepatitis C Infection and Hepatocellular Carcinoma: Expert Review.
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PMID: 30878469
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Hepatocellular Carcinoma Screening Is Associated With Increased Survival of Patients With Cirrhosis.
Authors: Choi D.T. , Kum H.C. , Park S. , Ohsfeldt R.L. , Shen Y. , Parikh N.D. , Singal A.G. .
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