The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study
NCT ID: NCT01831037
Last Updated: 2015-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-07-31
2019-12-31
Brief Summary
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Detailed Description
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OBJECTIVES: The proposed hypothesis is that patients with regression of liver fibrosis have decreased risk for HCC. Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, during the 3-7 years after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.
METHODS: Patients 18-70 year-old with cirrhosis will be identified from hepatology clinics in 4 academic centers in North America. FT/TE will be obtained before the start of antivirals and yearly thereafter (prospective arm). A retrolective arm of all patients treated no earlier than Jan/2009 will also be included. In this group, baseline FT/TE will be performed off treatment (CHC) or after initial phase of therapy (CHB), and yearly thereafter. During baseline and yearly visits other factors possibly affecting HCC development will be investigated (family history, comorbidities, BMI, diet, etc.). Patients will be classified as having or having not undergone regression of fibrosis after a 3-year follow up, depending on FT and TE evolution. During follow up, all patients will undergo 6-month imaging as part of their routine HCC surveillance. Based on power calculations, enrollment should stop after 924 patients have been recruited. Kaplan-Meier and Cox regression models will be used to analyze data.
PATIENT OUTCOMES: ROLFH study uses state-of-the-art noninvasive markers of liver fibrosis to test whether reversed fibrosis decreases the risk of HCC. We believe this study will lead to a better understanding of HCC risk factors, improved patient counseling and decision making, optimized screening and allocation of health resources, and decreased healthcare costs.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Regression of fibrosis
Group conformed by patients experiencing improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.
Regression of fibrosis
Regression of fibrosis will be defined by assessing yearly evolution of noninvasive markers in patients who received antiviral therapy before start of the study, and by comparing baseline markers before start of antiviral therapy to those on subsequent yearly visits in patients prospective recruited (\>50% of cases).
Specific risk factors related to hepatocellular carcinoma
Such as: family history of liver cancer; body mass index; alcohol, smoking and recreational drug use status; dietary habits, including use of caffeinated drinks; comorbidities such as type 2 diabetes mellitus; use of medications for other chronic diseases such as statins and angiotensin-converting enzyme inhibitors.
No regression of fibrosis
Group conformed by patients not showing the predefined improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.
No interventions assigned to this group
Interventions
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Regression of fibrosis
Regression of fibrosis will be defined by assessing yearly evolution of noninvasive markers in patients who received antiviral therapy before start of the study, and by comparing baseline markers before start of antiviral therapy to those on subsequent yearly visits in patients prospective recruited (\>50% of cases).
Specific risk factors related to hepatocellular carcinoma
Such as: family history of liver cancer; body mass index; alcohol, smoking and recreational drug use status; dietary habits, including use of caffeinated drinks; comorbidities such as type 2 diabetes mellitus; use of medications for other chronic diseases such as statins and angiotensin-converting enzyme inhibitors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic liver disease due to CHC or CHB.
* Starting of disease-specific treatment no earlier than January of 2010. Treatment could consist of:
* combination therapy with peginterferon and ribavirin, with or without a direct-acting viral agent in CHC;
* single or combination therapy containing peginterferon, entecavir, or tenofovir in CHB.
* Established cirrhosis on liver biopsy (METAVIR F4) obtained before starting disease-specific treatment.
* In patients without liver biopsy, any of the following criteria will be used as a surrogate to define cirrhosis:
* History of spleen \>13 cm, bilirubin \>2, albumin \<3.5, INR \>1.5 (2 of 3 criteria).
* History of APRI (\[AST/ULN\]/platelets x 100) \>2, and esophageal varices or ascites.
* History of Fibrotest/Fibrosure \>0.74, and TE \>12.5 kPa (M-probe) or \>10 kPa (XL-probe).
Exclusion Criteria
* Conditions limiting Fibrotest/Fibrosure read: hemolysis, Gilbert's syndrome, autoimmune disease.
* Conditions limiting TE read: ascites, heart failure with retrograde vascular congestion, extrahepatic cholestasis.
* Pregnancy or implantable active medical device (such as pacemaker or defibrillator).
18 Years
70 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
University of Toronto
OTHER
University of Calgary
OTHER
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Andres Duarte-Rojo, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Jonathan A Dranoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Calgary
Calgary, Alberta, Canada
University of Toronto
Toronto, Ontario, Canada
Countries
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References
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El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061.
Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.
Barritt AS 4th, Fried MW. Maximizing opportunities and avoiding mistakes in triple therapy for hepatitis C virus. Gastroenterology. 2012 May;142(6):1314-1323.e1. doi: 10.1053/j.gastro.2012.02.013.
van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, Duarte-Rojo A, Heathcote EJ, Manns MP, Kuske L, Zeuzem S, Hofmann WP, de Knegt RJ, Hansen BE, Janssen HL. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012 Dec 26;308(24):2584-93. doi: 10.1001/jama.2012.144878.
Duarte-Rojo A, Altamirano JT, Feld JJ. Noninvasive markers of fibrosis: key concepts for improving accuracy in daily clinical practice. Ann Hepatol. 2012 Jul-Aug;11(4):426-39.
Myers RP, Pomier-Layrargues G, Kirsch R, Pollett A, Duarte-Rojo A, Wong D, Beaton M, Levstik M, Crotty P, Elkashab M. Feasibility and diagnostic performance of the FibroScan XL probe for liver stiffness measurement in overweight and obese patients. Hepatology. 2012 Jan;55(1):199-208. doi: 10.1002/hep.24624. Epub 2011 Nov 18.
Myers RP, Pomier-Layrargues G, Kirsch R, Pollett A, Beaton M, Levstik M, Duarte-Rojo A, Wong D, Crotty P, Elkashab M. Discordance in fibrosis staging between liver biopsy and transient elastography using the FibroScan XL probe. J Hepatol. 2012 Mar;56(3):564-70. doi: 10.1016/j.jhep.2011.10.007. Epub 2011 Oct 23.
Other Identifiers
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137855
Identifier Type: -
Identifier Source: org_study_id
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