Early Detection of Alcoholic Liver Disease

NCT04070508 | Withdrawn DMC

• 1 other identifier: STUDY19020346
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis. The investigators will include patients 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy). Liver fibrosis will be estimated by FibroScan®. A designed questionnaire for studying environmental and psychosocial factors will be filled by the included patients, and blood samples will be obtained to study genetic and epigenetic factors. The patients with advance fibrosis will be referred to the specialist for surveillance and treatment according to current clinical guidelines.

Conditions

Alcoholic Liver Disease; Alcoholic Fibrosis of Liver; Alcoholic Cirrhosis; Excessive Drinking; Alcohol Abuse; Alcohol Use Disorder; Alcohol Dependence; Alcohol-Related Disorders

Keywords

early detection; alcoholic liver disease; alcohol

Outcome Measures

Primary Outcomes (1)

• Advanced fibrosis and cirrhosis assessed by FibroScan

  Prevalence of advanced liver fibrosis and cirrhosis among patients with excessive alcohol intake using FibroScan. Cut-off value for advanced fibrosis (F3) \>8 kPa.

  baseline

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy).

You may qualify if:

• Patients diagnosed with an alcohol use disorder (AUD) identification test (AUDIT) with a total score of 8 or more or patients with a score lower than 8 in the AUDIT test but for whom there is a high suspicion of current or recent (within one year) AUD based on medical history or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, and/or alcohol-induced organ involvement other than decompensated liver disease.
• Patients who admit having a persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men.
• Patients with abnormal AST, ALT, GGT and/or bilirubin.
• years of age or older.
• Signed informed consent.

You may not qualify if:

• Patients with a history of liver disease or decompensated advanced liver disease (i.e: jaundice episodes, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known hepatocellular carcinoma.
• Patients with severe extrahepatic disease or terminal illness.

Sponsors & Collaborators

• University of Pittsburgh: lead

Related Publications (10)

• Shah ND, Ventura-Cots M, Abraldes JG, Alboraie M, Alfadhli A, Argemi J, Badia-Aranda E, Arus-Soler E, Barritt AS 4th, Bessone F, Biryukova M, Carrilho FJ, Fernandez MC, Dorta Guiridi Z, El Kassas M, Eng-Kiong T, Queiroz Farias A, George J, Gui W, Thurairajah PH, Hsiang JC, Husic-Selimovic A, Isakov V, Karoney M, Kim W, Kluwe J, Kochhar R, Dhaka N, Costa PM, Nabeshima Pharm MA, Ono SK, Reis D, Rodil A, Domech CR, Saez-Royuela F, Scheurich C, Siow W, Sivac-Burina N, Dos Santos Traquino ES, Some F, Spreckic S, Tan S, Vorobioff J, Wandera A, Wu P, Yacoub M, Yang L, Yu Y, Zahiragic N, Zhang C, Cortez-Pinto H, Bataller R. Alcohol-Related Liver Disease Is Rarely Detected at Early Stages Compared With Liver Diseases of Other Etiologies Worldwide. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2320-2329.e12. doi: 10.1016/j.cgh.2019.01.026. Epub 2019 Jan 29.

  PMID: 30708110 BACKGROUND

• Altamirano J, Bataller R. Alcoholic liver disease: pathogenesis and new targets for therapy. Nat Rev Gastroenterol Hepatol. 2011 Aug 9;8(9):491-501. doi: 10.1038/nrgastro.2011.134.

  PMID: 21826088 BACKGROUND

• Raynard B, Balian A, Fallik D, Capron F, Bedossa P, Chaput JC, Naveau S. Risk factors of fibrosis in alcohol-induced liver disease. Hepatology. 2002 Mar;35(3):635-8. doi: 10.1053/jhep.2002.31782.

  PMID: 11870378 BACKGROUND

• Lackner C, Spindelboeck W, Haybaeck J, Douschan P, Rainer F, Terracciano L, Haas J, Berghold A, Bataller R, Stauber RE. Histological parameters and alcohol abstinence determine long-term prognosis in patients with alcoholic liver disease. J Hepatol. 2017 Mar;66(3):610-618. doi: 10.1016/j.jhep.2016.11.011. Epub 2016 Nov 25.

  PMID: 27894795 BACKGROUND

• Muntaner L, Altamirano JT, Augustin S, Gonzalez A, Esteban R, Guardia J, Genesca J. High doses of beta-blockers and alcohol abstinence improve long-term rebleeding and mortality in cirrhotic patients after an acute variceal bleeding. Liver Int. 2010 Sep;30(8):1123-30. doi: 10.1111/j.1478-3231.2010.02287.x. Epub 2010 Jun 1.

  PMID: 20536715 BACKGROUND

• Mueller S, Seitz HK, Rausch V. Non-invasive diagnosis of alcoholic liver disease. World J Gastroenterol. 2014 Oct 28;20(40):14626-41. doi: 10.3748/wjg.v20.i40.14626.

  PMID: 25356026 BACKGROUND

• Buch S, Stickel F, Trepo E, Way M, Herrmann A, Nischalke HD, Brosch M, Rosendahl J, Berg T, Ridinger M, Rietschel M, McQuillin A, Frank J, Kiefer F, Schreiber S, Lieb W, Soyka M, Semmo N, Aigner E, Datz C, Schmelz R, Bruckner S, Zeissig S, Stephan AM, Wodarz N, Deviere J, Clumeck N, Sarrazin C, Lammert F, Gustot T, Deltenre P, Volzke H, Lerch MM, Mayerle J, Eyer F, Schafmayer C, Cichon S, Nothen MM, Nothnagel M, Ellinghaus D, Huse K, Franke A, Zopf S, Hellerbrand C, Moreno C, Franchimont D, Morgan MY, Hampe J. A genome-wide association study confirms PNPLA3 and identifies TM6SF2 and MBOAT7 as risk loci for alcohol-related cirrhosis. Nat Genet. 2015 Dec;47(12):1443-8. doi: 10.1038/ng.3417. Epub 2015 Oct 19.

  PMID: 26482880 BACKGROUND

• Bataller R, Gao B. Liver fibrosis in alcoholic liver disease. Semin Liver Dis. 2015 May;35(2):146-56. doi: 10.1055/s-0035-1550054. Epub 2015 May 14.

  PMID: 25974900 BACKGROUND

• Moran-Salvador E, Mann J. Epigenetics and Liver Fibrosis. Cell Mol Gastroenterol Hepatol. 2017 Apr 26;4(1):125-134. doi: 10.1016/j.jcmgh.2017.04.007. eCollection 2017 Jul.

  PMID: 28593184 BACKGROUND

• Singal AK, Bataller R, Ahn J, Kamath PS, Shah VH. ACG Clinical Guideline: Alcoholic Liver Disease. Am J Gastroenterol. 2018 Feb;113(2):175-194. doi: 10.1038/ajg.2017.469. Epub 2018 Jan 16.

  PMID: 29336434 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The samples collected in this study including blood, urine, liver tissue and saliva.

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Liver Cirrhosis, Alcoholic; Alcoholism; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• RAMON BATALLER, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: April 1, 2023
• Primary Completion: October 3, 2023
• Study Completion: November 3, 2025
• Last Updated: March 17, 2023

Record last verified: 2023-03