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Early Detection of Alcoholic Liver Disease

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ClinicalTrials.gov Identifier: NCT04070508
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Ramon Bataller, University of Pittsburgh

Study Description
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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.


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

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Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Early Detection of Advanced Liver Fibrosis in Patients With Excessive Alcohol Intake
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 3, 2023
Estimated Study Completion Date : November 3, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Advanced fibrosis and cirrhosis assessed by FibroScan [ Time Frame: baseline ]

    Prevalence of advanced liver fibrosis and cirrhosis among patients with excessive alcohol intake using FibroScan.

    Cut-off value for advanced fibrosis (F3) >8 kPa.



Biospecimen Retention:   Samples With DNA
The samples collected in this study including blood, urine, liver tissue and saliva.

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • 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.
  • 21 years of age or older.
  • Signed informed consent.

Exclusion Criteria:

  • 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.
  • Patients who are pregnant or breast-feeding. However, pre-menopausal women capable of bearing children will be allowed to participate in the study provided they have a reliable method of birth control and have a negative pregnancy test prior to inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070508


Contacts
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Contact: DALIA ELENA MORALES ARRAEZ, MD +1(412)383-4818 daliama@pitt.edu
Contact: Alex Myint, MD +1(412)672-5766 myintah2@upmc.edu

Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: RAMON BATALLER, MD, PhD University of Pittsburgh
More Information
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Publications:
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.

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Responsible Party: Ramon Bataller, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04070508    
Other Study ID Numbers: STUDY19020346
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramon Bataller, University of Pittsburgh:
early detection
alcoholic liver disease
alcohol
Additional relevant MeSH terms:
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Liver Diseases
Liver Diseases, Alcoholic
Liver Cirrhosis, Alcoholic
Disease
Fibrosis
Alcoholism
Alcohol-Related Disorders
 Pathologic Processes
Digestive System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Induced Disorders
Liver Cirrhosis